Thursday, 25 May 2017

Market Size of Coca Cola

Coca Cola is one of the leading beverage companies in Pakistan. It covers the large market segment. From the facts it is revealed that the market for coca cola as mentioned in the SWOT analysis segment is encouraging. It is the second largest usage in Pakistan. Still it has a great potential in Pakistan market. It focuses on it deficiencies and try to over come it than it will definitely grow more than any other beverage company in Pakistan. So it has a large margin for growth.

Growth rate Coca Cola

In Pakistan market the growth rate is 22% which is a significant rate. Similarly In Asia region the amount of revenues which company earn is 5052 dollar.

Market Share

Coca cola has doubled its market share in Pakistan, in recent years its market share was 16% but in 2007 its market share increased up to 36%, on the other hand its competitors share is going down day by day.
Coca Cola is world leader in beverages, and is on the way to success in Pakistan and has crossed the Pepsi last year..

Major factors influencing the level of demand of the product

There are a lot of factors that affect the demand of the product. The list of these factors is given below

·         Price

Price is the major factor that affects the demand of the product. If the price Is not suitable to the consumers or customers than they will switch of the product.

·         Quality

If a company provides the quality services or products than the demand of the product also increases. In the quality of the product the consistency in the performance of the product is very important.

·         Supply

Supply and the demand of the product are the market forces and played the main role in the product demand. If the supply of the product decreased than in some cases the demand of the product increase as well as the price f the product can also increased. 

·         Taste

Taste of product is the major factor that affects the demand of the product. Like if the product is of good taste than the future demand of the product will increase and vise versa. If customers don’t find the taste of product according to their taste, than they will not buy that product in future.

·         Number of users

If the number of users increase in the market than the demand of the product also increases.

·         Income

Income level of the customers had a great impact on the demand of the product. It directly relates to the purchasing power of the customer. If customer has a purchasing power than definitely he can buy the product which he/she demand.

·         Competitors

Competitors are the biggest threat to the demand of product. If competitors offer the same products as the company offers than the customers got more alternatives. So increased alternatives, increases the bargaining power of the customers and they can switch of to more suitable product.

Can the market be broken down in to segments?

The coca Cola has a wide range of consumer. Though its market is very large and almost all are f its customers regardless of age and gender but the youngsters are it’s the largest most favorable target audiences. This is the reason they choose youngster in their advertisement as well.
Company can also largely focus on youngsters to set the target market. But their current strategy is most suitable because customers regardless of age factor like Coca Cola as soft drink. 

Product Life Cycle

Products go through various steps throughout their useful lives.  They are introduced, grow, mature and eventually decline.  In the introduction phase of the life cycle, start-up expenses are high and sales are low.  This is the stage in which the product in placed in the market for consumer use.  Sales begin to increase and expenses tend to decrease during the growth phase.  This is the point in which the product becomes more known in the market and consumers begin purchasing.  During the mature phase of the product life cycle, the company must re-examine the product and determine new ways to make it marketable.  Consumers begin to take the product for granted and no longer necessarily choose it first.  If a new product comes in at this point with new, more attractive features, it can force the product into the decline stage.  Eventually sales will begin to decline and the company must decide whether to continue with production or to part ways with the product.

Coca-Cola has been in the industry since the nineteenth century, so if they continue with the same marketing strategy, then they will send themselves irrevocably into the decline stage. Coca-Cola (Coke) is in maturity stage but gradually moving towards the declining stage of the product life cycle. Management has to pay special attention to products during this stage of the product life-cycle. The company must now determine whether they will stop producing Coca-Cola, change the soda, find new uses for it, seek new markets for the soft drink or if they will maintain their current strategy (Peter, 2006).  At the moment, the soft drink company is attempting to effectively seek new markets.  Coke’s core product, Coca-Cola, has received many criticisms because of the health issues that arise from its use of caffeine and high fructose corn syrup.

Coke knows that they must begin to acknowledge the shift in consumer tastes in order to remain competitive.  They have done this successfully many times in the past, as can be seen with the introduction of their popular Diet Coke brand.  Coke must break into the non-carbonated drink market in order to acknowledge consumer’s new interest in healthy drinks.

During the maturity stage, products usually go through a slowdown in sales growth. According to Coca-Cola’s 2001 annual report, sales have increased by 1.02% compared to last year. This percentage has no comparison to the high level of growth Coca-Cola enjoyed during its growth stage.

Fluctuation in demand with cyclical factors

Nothing is in isolation in this world. The brands also have personality and thus also affected by the different situations like weather, occasions, events, economical factors etc.

Demand of the product doesn’t remain consistent because it exists in the real world which is gradually changing. Coca Cola advertisement has a great affect in its demand. Its advertisement removes the risk of no use of brands on different extreme weathers like in winters. Its ads stimulate its purchase regardless of weather or cyclic factors.

Similarly on different events the buying patterns also changes. Company has a great strategy that they use those events as their strengths and advertise their product on right time which results in increase sale. 

International Share:

Coke is considered to be the market leader on international basis. It occupies 80% market share worldwide, while Pepsi has 20% share.

Share in Pakistan

Coke is having 35% market share while Pepsi is having 65% Market share in Pakistan this is due to some reasons. Whereas in Gujranwala, Coke is having 49% market share and Pepsi is having 51% market share. This rate shows that Pepsi is having more market share than Coke in Pakistan.

Coca Cola Target Market

Coca Cola takes every customer as target and potential customer who is thirsty. All age groups are being target but the most potential is the age group from 18-25 that covers around 40% of total age segments

Age

The target market for the Coca Cola is based on age. The target audience of Coca Cola is youngster or youth. It is a wide range for targeting. It ranges from the age of 15-25 and also reaches to 40 plus, as they are serving this age group also. Their targeting not based on gender but the results also show that both genders like this product and use it. 

Gender

Surprisingly Coca Cola segments Pakistani Market with a percentage ratio of 58% females and 42% male.
Life style; busy life style (face shortage of time) and mobile generation
Family; dependent on their family
Occupation; students and family oriented people
Nature; fun loving and entertainment loving
Socio economic status; upper lower class and lower class

Customer’s Media Habits

There are some habits which are given as follows’
·         The target audience of the coca Cola brand is loved to have exposure to media.
·         They are the mobile generation and spend lot of time on MMS and SMS chatting.
·         They spend most of the time on enjoying music.
·         They spend their home time on watching TVs.

Threats to Coca Cola

Competitors

In beverage industry the competition very high so, to remain on the top position the company need lot of finance as well as lot of organizational changes. Coca Cola have not only competitors like Pepsi, Nestle and others also giving tough time.

Removal of Barriers

Globalization removes the barriers so it also attracts the new comer companies for having the same business. Due this the many little companies enter into the market and decrease the market share as well as the sale of the product.

Cultural Differences

For a company the most common threat is the cultural differences because every nation or every geographic boundary has different culture. Same threat faced by Coca Cola Company. Because they have wide network so face this problem as well.

Local Companies


The local companies also are the major threat to Coca Cola company like in Pakistan the Madni Cola, Noras , Amrat Cola etc are the threats for the company. Though the sale not affected at larger level but this have some impact as well.

Weaknesses of Coca Cola

Availability of Product

The Coca Cola product though has extensive distribution but in Pakistan it fasces non availability problem. It is the biggest weakness that if product is not available on time than it has a negative image on the min o the customers.

Promotional Activities

In Pakistan the company ignores the most important element which is promotion. On the other hand it is seen that Pepsi is concerning a lot on promotional activates.

Taste Differentiation

Coca Cola is not being successful in differentiating its taste from other brands like Pepsi. Rarely a small number of consumers can identify its taste from Pepsi. This thing also has a negative impact and consumers feel no problem in switching to Pepsi because of taste. 

Sunday, 21 May 2017


This training module is based on the revised text on good practices for pharmaceutical quality control laboratories, It is divided into three parts and will focus on

Part one. Management and infrastructure

1. Organization and management
2. Quality management system
3. Control of documentation
4. Records
5. Data-processing equipment
6. Personnel
7. Premises
8. Equipment, instruments and other devices
9. Contracts

Part two. Materials, equipment, instruments and other devices

10. Reagents
11. Reference substances and reference materials
12. Calibration, verification of performance and qualification of equipment, instruments and other devices
13. Traceability

Part three. Working procedures and safety

14. Incoming samples
15. Analytical worksheet
16. Validation of analytical procedures
17. Testing
18. Evaluation of test results
19. Certificate of analysis
20. Retained samples

Safety

21. General rules
 Quality Control

Introduction of Good Practices for Quality Control

Part 1:  Management and infrastructure
Part 2:  Materials, equipment, instruments and devices
Part 3:  Working procedures, documents and safety
Part 4:  Inspecting the laboratory

Management and infrastructure

Objectives

To discuss Good Practices for Quality Control laboratories including quality systems and infrastructure
To understand the role and importance of the Quality Control laboratory in:
–sampling and testing
–materials, equipment and systems
To discuss approaches in inspecting a Quality Control laboratory

General

Many of the recommendations relevant to quality control testing at the site of the pharmaceutical manufacturer. In line, and beyond ISO17025. The QC laboratory provides a service and is like a manufacturing unit – its “products” include test results, advice and investigations. It needs

- buildings, personnel, resources

- equipment, raw materials

- quality systems

- General considerations

These guidelines provide advice on the quality management system within which the analysis of active pharmaceutical ingredients (APIs), excipients and pharmaceutical products should be performed to demonstrate that reliable results are obtained.

All the necessary resources should be available to ensure the maintenance of the laboratory, as well as for an appropriate infrastructure and energy supply. Means and procedures should be in place (in case of possible supply problems) to ensure that the laboratory can continue its activities. 

These guidelines are applicable to any pharmaceutical quality control laboratory, be it national, commercial or nongovernmental. 

However, they do not include guidance for those laboratories involved in the testing of biological products, e.g. vaccines and blood products. Separate guidance for such laboratories is available.
These guidelines are consistent with the requirements of the WHO guidelines for good manufacturing practices (1) and with the requirements of the International Standard ISO/IEC 17025:2005 (2), and provide detailed guidance for laboratories performing quality control of medicines. 

There is also a specific guidance for microbiology laboratories (separate).

The good practice outlined in the presentation is to be considered as a general guide and it may be adapted to meet individual needs provided that an equivalent level of quality assurance is achieved

General

- Activities include sampling, testing
- APIs, excipients, finished products
- Components, packaging materials
- Specifications and test methods
- Planning and organization of work
- General considerations

Quality control laboratories may perform some or all quality control activities, e.g. sampling, testing of APIs, excipients, packaging materials and/ or pharmaceutical products, stability testing, testing against specifications and investigative testing.
For the quality of a medicine sample to be correctly assessed:
- The submission of a sample of an API, excipient or pharmaceutical product or a suspected counterfeit material to the laboratory, selected in accordance with national requirements, should be accompanied by a statement of the reason why the analysis has been requested.
- The analysis should be correctly planned and meticulously executed.
- The results should be competently evaluated to determine whether the sample complies with the specifications or other relevant criteria.

Management and infrastructure:

- Organization and management
- Quality management systems
- Control of documentation and records
- Data processing equipment
- Personnel
- Premises, equipment, instruments and other devices
- Contracts

Organization and management: (1)

- Function in accordance with national legislation
- Operate in accordance with good practice norms and standards
- See also general texts on Good Manufacturing Practices and Good Practices in Quality control
- WHO Technical Report Series, No. 908, 2003, Annex 4

Organization and management

Personnel

- Managerial and technical positions to ensure operation in  accordance with quality systems
- No conflict of interest
- Organizational chart and job descriptions
- Supervision and training

Organization and management

The laboratory should have

- Managerial and technical personnel with authority and resources
- Arrangements to prevent commercial, political, financial and other pressures or conflicts of interest
- Policy and procedure in place to ensure confidentiality of— information contained in marketing authorizations,

— transfer of results or reports,

— and to protect data in archives (paper and electronic);

The laboratory should:

(a) have managerial and technical personnel with the authority and resources needed to carry out their duties and to identify the occurrence of departures from the quality management system or the procedures for performing tests and/or calibrations, validation and verification, and to initiate actions to prevent or minimize such departures;
(b) have arrangements to ensure that its management and personnel are not subject to commercial, political, financial and other pressures or conflicts of interest that may adversely affect the quality of their work;
(c) have a policy and procedure in place to ensure confidentiality of
— information contained in marketing authorizations,
— transfer of results or reports,
— and to protect data in archives (paper and electronic);

The laboratory must

(a) have managerial and technical personnel with the authority and resources needed to carry out their duties and to identify the occurrence of departures from the quality system or the procedures for performing tests and/or calibrations, validation and verification, and to initiate actions to prevent or minimize such departures; 
(b) have arrangements to ensure that its management and personnel are commercial, political, financial and other pressures or conflict of interest that may adversely affect the quality of their work;
(c) define, with the aid of organizational charts, the organization and management structure of the laboratory, its place in any parent organization such as the ministry or the drug regulatory authority, and the relationships between management, technical operations, support services and the quality system;
(d) specify the responsibility, authority and inter-relationships of all personnel who manage, perform or verify the work which affects the quality of the tests and/or calibrations, validations and verification;
(e) provide adequate supervision of staff, including trainees, by persons familiar with the test and/or calibration, validation and verification methods and procedures, as well as their purpose and the assessment of the  results;
(f) have a technical manager, which has overall responsibility for the technical operations, and the provision of resources needed to ensure the required quality of laboratory operations; and
(g) have appropriate safety procedures (see Part Four).

Organization and management

The laboratory should:

Have organizational charts showing e.g. relationships between management, technical operations, support services and the quality management system
Specify  personnel responsibility, authority and interrelationships
Nominate trained substitutes/deputies for personnel
Provide adequate supervision of staff

The laboratory should:


(d) define, with the aid of organizational charts, the organization and management structure of the laboratory, its place in any parent organization (such as the ministry or the NMRA in the case of a national pharmaceutical quality control laboratory), and the relationships between management, technical operations, support services and the quality management system;
(e) specify the responsibility, authority and interrelationships of all personnel who manage, perform or verify work which affects the quality of the tests and/or calibrations, validations and verifications;
(f) ensure the precise allocation of responsibilities, particularly in the designation of specific units for particular types of medicines;
(g) nominate trained substitutes/deputies for key management and specialized scientific personnel;
(h) provide adequate supervision of staff, including trainees, by persons familiar with the test and/or calibration, validation and verification methods and procedures, as well as their purpose and the assessment of the results;

Organization and management

The laboratory should have:
Management which has overall responsibility
A designated quality manager  (ensure compliance with the quality management system). Direct access to top management
Adequate information flow
Traceability of the samples (from receipt to test report completion)
Up-to-date specifications and related documents (paper or electronic)  and safety procedures 

The laboratory should:


(i) have management which has overall responsibility for the technical operations and the provision of resources needed to ensure the required quality of laboratory operations;
(j) designate a member of staff as quality manager who, irrespective of other duties he/she may have, will ensure compliance with the quality management system. The
nominated quality manager should have direct access to the highest level of management at which decisions are taken on laboratory policies or resources;
(k) ensure adequate information flow between staff at all levels. Staff are to be made aware of the relevance and importance of their activities;
(l) ensure the traceability of the sample from receipt, throughout the stages of testing, to the completion of the analytical test report;
(m) maintain an up-to-date collection of all specifications and related documents (paper or electronic) used in the laboratory; and (n) have appropriate safety procedures (see Part four).

Organization and management

A registry should be kept and may include information on
receiving, distributing and supervising the consignment of the samples
keeping records on all incoming samples and accompanying documents.
Ensure communication and coordination between the staff involved in the testing of the same sample in different units.
1.4 The laboratory should maintain a registry with the following functions:
(a) receiving, distributing and supervising the consignment of the samples to the specific units; and
(b) keeping records on all incoming samples and accompanying documents.

- In a large laboratory, it is necessary to guarantee communication and coordination between the staff involved in the testing of the same sample in different units.

Quality  Management System (QMS)

Establish, implement and maintain QMS covering
Type of activities, range and volume of testing and/or calibration, validation and verification
Policies, systems, programmes, procedures and instructions
Communicated, available, understood and implemented
Documented in a quality manual
available to the laboratory personnel
maintained and updated by a responsible person

Quality management system

The laboratory or organization management should establish, implement and maintain a quality management system appropriate to the scope of its activities, including the type, range and volume of testing and/or calibration, validation and verification activities it undertakes. The laboratory management should ensure that its policies, systems, programmes, procedures and instructions are described to the extent necessary to enable the laboratory to assure the quality of the test results that it generates. The documentation used in this quality management system should be communicated, available to, and understood and implemented by, the appropriate personnel. The elements of this system should be documented, e.g. in a quality manual, for the organization as a whole and/or for a laboratory within the organization.

Note: Quality control laboratories of a manufacturer may have this information in other documents than a quality manual.

The quality manual should  refer to at least (1):

Quality  policy
Organizational chart; operational and functional activities
Operational and functional activities
Structure of documents
Internal QM procedures
Procedures for tests

The quality manual should contain as a minimum:

(a) a quality policy statement, including at least the following:
(i) a statement of the laboratory management’s intentions with respect to the standard of service it will provide, 
(ii) a commitment to establishing, implementing and maintaining an effective quality management system,
(iii) the laboratory management’s commitment to good professional practice and quality of testing, calibration, validation and verification,
(iv) the laboratory management’s commitment to compliance with the content of these guidelines,
(v) a requirement that all personnel concerned with testing and calibration activities within the laboratory familiarize themselves with the documentation concerning quality and the implementation of the policies and procedures in their work;
(b) the structure of the laboratory (organizational chart);
(c) the operational and functional activities pertaining to quality, so that the extent and the limits of the responsibilities are clearly defined;
(d) outline of the structure of documentation used in the laboratory quality management system;
(e) the general internal quality management procedures;
(f) references to specific procedures for each test;
(g) information on the appropriate qualifications, experience and competencies that personnel are required to possess;
(h) information on initial and in-service training of staff;
(i) a policy for internal and external audit;
(j) a policy for implementing and verifying corrective and preventive actions;
(k) a policy for dealing with complaints;
(l) a policy for performing management reviews of the quality management system;
(m) a policy for selecting, establishing and approving analytical procedures;
(n) a policy for handling of OOS results;
(o) a policy for the employment of appropriate reference substances and reference materials;
(p) a policy for participation in appropriate proficiency testing schemes and collaborative trials and the evaluation of the performance (applicable to national pharmaceutical quality control laboratories, but may be applied by other laboratories); and
(q) a policy to select service providers and suppliers.

The quality manual should  refer to at least

Qualifications, experience and competencies of personnel
Initial and in-service training
Internal and external audit
Implementing and verifying corrective and preventive actions
Dealing with complaints
Management reviews
Selecting, establishing and approving analytical procedures

The quality manual should contain at least

Handling of OOS results
Reference substances and reference materials
Participation in appropriate proficiency testing schemes and collaborative trials and the evaluation of the performance

Selection of service providers and suppliers

The quality policy statement should include at least: intentions and commitment  to:
Standard of service it will provide
An effective quality management system
Good professional practice and quality of testing, calibration, validation and verification
Compliance with good practices guidelines
Personnel  commitments to quality and the implementation of the policies and procedures in their work

A quality policy statement, including at least the following:

(i) a statement of the laboratory management’s intentions with respect to the standard of service it will provide, 
(ii) a commitment to establishing, implementing and maintaining an effective quality management system,
(iii) the laboratory management’s commitment to good professional practice and quality of testing, calibration, validation and verification,
(iv) the laboratory management’s commitment to compliance with the content of these guidelines,
(v) a requirement that all personnel concerned with testing and calibration activities within the laboratory familiarize themselves with the documentation concerning quality and the implementation of the policies and procedures in their work;

Authorized, written SOPs should be established, implemented and maintained. Examples include procedures on:

Personnel matters, including qualifications, training, clothing and hygiene
Change control; internal audits
Dealing with complaints
Corrective and preventive actions
Purchase and receipt of materials (e.g. samples, reagents)

The laboratory should establish, implement and maintain authorized written SOPs including, but not limited to, administrative and technical operations, such as:

(a) personnel matters, including qualifications, training, clothing and hygiene;
(b) the change control;
(c) internal audit;
(d) dealing with complaints;
(e) implementation and verification of corrective and preventive actions;
(f) the purchase and receipt of consignments of materials (e.g. samples, reagents);
(g) the procurement, preparation and control of reference substances and reference materials (8);
(h) the internal labelling, quarantine and storage of materials;
(i) the qualification of equipment (11);
(j) the calibration of equipment;
(k) preventive maintenance and verification of instruments and equipment;
(l) sampling, if performed by the laboratory, and visual inspection;
(m) the testing of samples with descriptions of the methods and equipment used;
(n) atypical and OOS results;
(o) validation of analytical procedures;
(p) cleaning of laboratory facilities, including bench tops, equipment, work stations, clean rooms (aseptic suites) and glassware; 
(q) monitoring of environmental conditions, e.g. temperature and humidity;
(r) monitoring storage conditions;
(s) disposal of reagents and solvent samples; and
(t) safety measures.

SOPs

Reference substances and reference materials - procurement, preparation and control
Internal labelling, quarantine and storage of materials
Qualification, calibration and verification of equipment
Preventive maintenance
Sampling, and testing of samples, atypical and OOS results

Validation of analytical procedures

2.3 The laboratory should establish, implement and maintain authorized written SOPs including, but not limited to, administrative and technical operations, such as:
(a) personnel matters, including qualifications, training, clothing and hygiene;
(b) the change control;
(c) internal audit;
(d) dealing with complaints;
(e) implementation and verification of corrective and preventive actions;
(f) the purchase and receipt of consignments of materials (e.g. samples, reagents);
(g) the procurement, preparation and control of reference substances and reference materials (8);
(h) the internal labelling, quarantine and storage of materials;
(i) the qualification of equipment (11);
(j) the calibration of equipment;
(k) preventive maintenance and verification of instruments and equipment;
(l) sampling, if performed by the laboratory, and visual inspection;
(m) the testing of samples with descriptions of the methods and equipment used;
(n) atypical and OOS results;
(o) validation of analytical procedures;
(p) cleaning of laboratory facilities, including bench tops, equipment, work stations, clean rooms (aseptic suites) and glassware; 
(q) monitoring of environmental conditions, e.g. temperature and humidity;
(r) monitoring storage conditions;
(s) disposal of reagents and solvent samples; and
(t) safety measures.

SOPs

- Cleaning of laboratory facilities, including bench tops, equipment, work stations, clean rooms (aseptic suites) and glassware
- Monitoring of environmental conditions, e.g. temperature and humidity
- Monitoring storage conditions
- Disposal of reagents and solvent samples; and
- Safety measures

2.3 The laboratory should establish, implement and maintain authorized written SOPs including, but not limited to, administrative and technical operations, such as:
(a) personnel matters, including qualifications, training, clothing and hygiene;
(b) the change control;
(c) internal audit;
(d) dealing with complaints;
(e) implementation and verification of corrective and preventive actions;
(f) the purchase and receipt of consignments of materials (e.g. samples, reagents);
(g) the procurement, preparation and control of reference substances and reference materials (8);
(h) the internal labelling, quarantine and storage of materials;
(i) the qualification of equipment (11);
(j) the calibration of equipment;
(k) preventive maintenance and verification of instruments and equipment;
(l) sampling, if performed by the laboratory, and visual inspection;
(m) the testing of samples with descriptions of the methods and equipment used;
(n) atypical and OOS results;
(o) validation of analytical procedures;
(p) cleaning of laboratory facilities, including bench tops, equipment, work stations, clean rooms (aseptic suites) and glassware; 
(q) monitoring of environmental conditions, e.g. temperature and humidity;
(r) monitoring storage conditions;
(s) disposal of reagents and solvent samples; and
(t) safety measures.
Laboratory activities systematically and periodically audited (internally and, where appropriate, by external audits or inspections) to verify compliance  - CAPA
Audits by trained and qualified personnel 
Planning and organizing internal audit
Regular management review (e.g. annually) to cover e.g.
audit or inspection reports
investigations  (complaints, atypical results) and CAPAs

2.4 The activities of the laboratory should be systematically and periodically audited (internally and, where appropriate, by external audits or inspections) to verify compliance with the requirements of the quality management system and to apply corrective and preventive actions, if necessary. The audits should be carried out by trained and qualified personnel, who are independent of the activity to be audited. The quality manager is responsible for planning and organizing internal audits addressing all elements of the quality management system. Such audits should be recorded, together with details of any corrective and preventive action taken.

Management review of quality issues should be regularly undertaken (at least annually), including: 

(a) reports on internal and external audits or inspections and any follow-up required to correct any deficiencies;
(b) the outcome of investigations carried out as a result of complaints received, doubtful (atypical) or aberrant results reported in collaborative trials and/or proficiency tests; and
(c) corrective actions applied and preventive actions introduced as a result of these investigations.

Quality management records should include reports from internal (and external if performed) audits and management reviews, as well as records of all complaints and their investigations, including records of possible corrective and preventive actions.

-
This training module is based on the revised text on good practices for pharmaceutical quality control laboratories, as published in WHO Technical Report Series, No. 957, 2010, Annex 1

It is divided into three parts and will focus on

Part one. Management and infrastructure
1. Organization and management
2. Quality management system
3. Control of documentation
4. Records
5. Data-processing equipment
6. Personnel
7. Premises
8. Equipment, instruments and other devices
9. Contracts

Part two. Materials, equipment, instruments and other devices
10. Reagents
11. Reference substances and reference materials
12. Calibration, verification of performance and qualification of equipment, instruments and other devices
13. Traceability

Part three. Working procedures and safety
14. Incoming samples
15. Analytical worksheet
16. Validation of analytical procedures
17. Testing
18. Evaluation of test results
19. Certificate of analysis
20. Retained samples

Safety

21. General rules
 Quality Control

Introduction

Part 1:  Management and infrastructure
Part 2:  Materials, equipment, instruments and devices
Part 3:  Working procedures, documents and safety
Part 4:  Inspecting the laboratory
Management and infrastructure
Objectives
lTo discuss Good Practices for Quality Control laboratories including quality systems and infrastructure
lTo understand the role and importance of the Quality Control laboratory in:
–sampling and testing
–materials, equipment and systems
lTo discuss approaches in inspecting a Quality Control laboratory

General

Many of the recommendations relevant to quality control testing at the site of the pharmaceutical manufacturer
In line, and beyond ISO17025
The QC laboratory provides a service and is like a manufacturing unit – its “products” include test results, advice and investigations
It needs
buildings, personnel, resources
equipment, raw materials
quality systems
General considerations

These guidelines provide advice on the quality management system within which the analysis of active pharmaceutical ingredients (APIs), excipients and pharmaceutical products should be performed to demonstrate that reliable results are obtained.

All the necessary resources should be available to ensure the maintenance of the laboratory, as well as for an appropriate infrastructure and energy supply. Means and procedures should be in place (in case of possible supply problems) to ensure that the laboratory can continue its activities.

These guidelines are applicable to any pharmaceutical quality control laboratory, be it national, commercial or nongovernmental.

However, they do not include guidance for those laboratories involved in the testing of biological products, e.g. vaccines and blood products. Separate guidance for such laboratories is available.

These guidelines are consistent with the requirements of the WHO guidelines for good manufacturing practices (1) and with the requirements of the International Standard ISO/IEC 17025:2005 (2), and provide detailed guidance for laboratories performing quality control of medicines.

There is also a specific guidance for microbiology laboratories (separate).

The good practice outlined in the presentation is to be considered as a general guide and it may be adapted to meet individual needs provided that an equivalent level of quality assurance is achieved.

General
Activities include sampling, testing
APIs, excipients, finished products
Components, packaging materials
Specifications and test methods
Planning and organization of work
General considerations

Quality control laboratories may perform some or all quality control activities, e.g. sampling, testing of APIs, excipients, packaging materials and/ or pharmaceutical products, stability testing, testing against specifications and investigative testing.

For the quality of a medicine sample to be correctly assessed:

• The submission of a sample of an API, excipient or pharmaceutical product or a suspected counterfeit material to the laboratory, selected in accordance with national requirements, should be accompanied by a statement of the reason why the analysis has been requested.
• The analysis should be correctly planned and meticulously executed.
• The results should be competently evaluated to determine whether the sample complies with the specifications or other relevant criteria.

Management and infrastructure:

Organization and management
Quality management systems
Control of documentation and records
Data processing equipment
Personnel
Premises, equipment, instruments and other devices
Contracts
Organization and management: (1)
Function in accordance with national legislation
Operate in accordance with good practice norms and standards
See also general texts on Good Manufacturing Practices and Good Practices in Quality control
WHO Technical Report Series, No. 908, 2003, Annex 4
Organization and management (2):
Personnel
Managerial and technical positions to ensure operation in  accordance with quality systems
No conflict of interest
Organizational chart and job descriptions
Supervision and training
Organization and management (3):
The laboratory should have:
Managerial and technical personnel with authority and resources
Arrangements to prevent commercial, political, financial and other pressures or conflicts of interest
Policy and procedure in place to ensure confidentiality of
— information contained in marketing authorizations,
— transfer of results or reports,
— and to protect data in archives (paper and electronic);
1.3 The laboratory should:
(a) have managerial and technical personnel with the authority and resources needed to carry out their duties and to identify the occurrence of departures from the quality management system or the procedures for performing tests and/or calibrations, validation and verification, and to initiate actions to prevent or minimize such departures;
(b) have arrangements to ensure that its management and personnel are not subject to commercial, political, financial and other pressures or conflicts of interest that may adversely affect the quality of their work;
(c) have a policy and procedure in place to ensure confidentiality of
— information contained in marketing authorizations,
— transfer of results or reports,
— and to protect data in archives (paper and electronic);

1.3 The laboratory must
(a) have managerial and technical personnel with the authority and resources needed to carry out their duties and to identify the occurrence of departures from the quality system or the procedures for performing tests and/or calibrations, validation and verification, and to initiate actions to prevent or minimize such departures;
(b) have arrangements to ensure that its management and personnel are commercial, political, financial and other pressures or conflict of interest that may adversely affect the quality of their work;
(c) define, with the aid of organizational charts, the organization and management structure of the laboratory, its place in any parent organization such as the ministry or the drug regulatory authority, and the relationships between management, technical operations, support services and the quality system;
(d) specify the responsibility, authority and inter-relationships of all personnel who manage, perform or verify the work which affects the quality of the tests and/or calibrations, validations and verifications;
(e) provide adequate supervision of staff, including trainees, by persons familiar with the test and/or calibration, validation and verification methods and procedures, as well as their purpose and the assessment of the  results;
(f) have a technical manager, which has overall responsibility for the technical operations, and the provision of resources needed to ensure the required quality of laboratory operations; and
(g) have appropriate safety procedures (see Part Four).
Organization and management (4):
The laboratory should:
Have organizational charts showing e.g. relationships between management, technical operations, support services and the quality management system
Specify  personnel responsibility, authority and interrelationships
Nominate trained substitutes/deputies for personnel
Provide adequate supervision of staff
1.3 The laboratory should:
(d) define, with the aid of organizational charts, the organization and management structure of the laboratory, its place in any parent organization (such as the ministry or the NMRA in the case of a national pharmaceutical quality control laboratory), and the relationships between management, technical operations, support services and the quality management system;
(e) specify the responsibility, authority and interrelationships of all personnel who manage, perform or verify work which affects the quality of the tests and/or calibrations, validations and verifications;
(f) ensure the precise allocation of responsibilities, particularly in the designation of specific units for particular types of medicines;
(g) nominate trained substitutes/deputies for key management and specialized scientific personnel;
(h) provide adequate supervision of staff, including trainees, by persons familiar with the test and/or calibration, validation and verification methods and procedures, as well as their purpose and the assessment of the results;
Organization and management (5):
The laboratory should have:
Management which has overall responsibility
A designated quality manager  (ensure compliance with the quality management system). Direct access to top management
Adequate information flow
Traceability of the samples (from receipt to test report completion)
Up-to-date specifications and related documents (paper or electronic)  and safety procedures
1.3 The laboratory should:
(i) have management which has overall responsibility for the technical operations and the provision of resources needed to ensure the required quality of laboratory operations;
(j) designate a member of staff as quality manager who, irrespective of other duties he/she may have, will ensure compliance with the quality management system. The
nominated quality manager should have direct access to the highest level of management at which decisions are taken on laboratory policies or resources;
(k) ensure adequate information flow between staff at all levels. Staff are to be made aware of the relevance and importance of their activities;
(l) ensure the traceability of the sample from receipt, throughout the stages of testing, to the completion of the analytical test report;
(m) maintain an up-to-date collection of all specifications and related documents (paper or electronic) used in the laboratory; and (n) have appropriate safety procedures (see Part four).
Organization and management (6):
A registry should be kept and may include information on
receiving, distributing and supervising the consignment of the samples
keeping records on all incoming samples and accompanying documents.
Ensure communication and coordination between the staff involved in the testing of the same sample in different units.
1.4 The laboratory should maintain a registry with the following functions:
(a) receiving, distributing and supervising the consignment of the samples to the specific units; and
(b) keeping records on all incoming samples and accompanying documents.

1.5 In a large laboratory, it is necessary to guarantee communication and coordination between the staff involved in the testing of the same sample in different units.

Quality  Management System (QMS)
Establish, implement and maintain QMS covering
Type of activities, range and volume of testing and/or calibration, validation and verification
Policies, systems, programmes, procedures and instructions
Communicated, available, understood and implemented
Documented in a quality manual
available to the laboratory personnel
maintained and updated by a responsible person

Quality management system

2.1 The laboratory or organization management should establish, implement and maintain a quality management system appropriate to the scope of its activities, including the type, range and volume of testing and/or calibration, validation and verification activities it undertakes. The laboratory management should ensure that its policies, systems, programmes, procedures and instructions are described to the extent necessary to enable the laboratory to assure the quality of the test results that it generates. The documentation used in this quality management system should be communicated, available to, and understood and implemented by, the appropriate personnel. The elements of this system should be documented, e.g. in a quality manual, for the organization as a whole and/or for a laboratory within the organization.
Note: Quality control laboratories of a manufacturer may have this information in other documents than a quality manual.
The quality manual should  refer to at least (1):
Quality  policy
Organizational chart; operational and functional activities
Operational and functional activities
Structure of documents
Internal QM procedures

Procedures for tests

2.2 The quality manual should contain as a minimum:
(a) a quality policy statement, including at least the following:
(i) a statement of the laboratory management’s intentions with respect to the standard of service it will provide,
(ii) a commitment to establishing, implementing and maintaining an effective quality management system,
(iii) the laboratory management’s commitment to good professional practice and quality of testing, calibration, validation and verification,
(iv) the laboratory management’s commitment to compliance with the content of these guidelines,
(v) a requirement that all personnel concerned with testing and calibration activities within the laboratory familiarize themselves with the documentation concerning quality and the implementation of the policies and procedures in their work;
(b) the structure of the laboratory (organizational chart);
(c) the operational and functional activities pertaining to quality, so that the extent and the limits of the responsibilities are clearly defined;
(d) outline of the structure of documentation used in the laboratory quality management system;
(e) the general internal quality management procedures;
(f) references to specific procedures for each test;
(g) information on the appropriate qualifications, experience and competencies that personnel are required to possess;
(h) information on initial and in-service training of staff;
(i) a policy for internal and external audit;
(j) a policy for implementing and verifying corrective and preventive actions;
(k) a policy for dealing with complaints;
(l) a policy for performing management reviews of the quality management system;
(m) a policy for selecting, establishing and approving analytical procedures;
(n) a policy for handling of OOS results;
(o) a policy for the employment of appropriate reference substances and reference materials;
(p) a policy for participation in appropriate proficiency testing schemes and collaborative trials and the evaluation of the performance (applicable to national pharmaceutical quality control laboratories, but may be applied by other laboratories); and
(q) a policy to select service providers and suppliers.

The quality manual should  refer to at least (2):
Qualifications, experience and competencies of personnel
Initial and in-service training
Internal and external audit
Implementing and verifying corrective and preventive actions
Dealing with complaints
Management reviews
Selecting, establishing and approving analytical procedures
The quality manual should contain at least (3):

Handling of OOS results
Reference substances and reference materials
Participation in appropriate proficiency testing schemes and collaborative trials and the evaluation of the performance
Selection of service providers and suppliers
The quality policy statement should include at least: intentions and commitment  to:

Standard of service it will provide

- An effective quality management system
- Good professional practice and quality of testing, calibration, validation and verification
- Compliance with good practices guidelines
- Personnel  commitments to quality and the implementation of the policies and procedures in their work a quality policy statement, including at least the following:
(i) a statement of the laboratory management’s intentions with respect to the standard of service it will provide,
(ii) a commitment to establishing, implementing and maintaining an effective quality management system,
(iii) the laboratory management’s commitment to good professional practice and quality of testing, calibration, validation and verification,
(iv) the laboratory management’s commitment to compliance with the content of these guidelines,
(v) a requirement that all personnel concerned with testing and calibration activities within the laboratory familiarize themselves with the documentation concerning quality and the implementation of the policies and procedures in their work;

Authorized, written SOPs should be established, implemented and maintained. Examples include procedures on:

Personnel matters, including qualifications, training, clothing and hygiene
Change control; internal audits
Dealing with complaints
Corrective and preventive actions
Purchase and receipt of materials (e.g. samples, reagents)
2.3 The laboratory should establish, implement and maintain authorized written SOPs including, but not limited to, administrative and technical operations, such as:
(a) personnel matters, including qualifications, training, clothing and hygiene;
(b) the change control;
(c) internal audit;
(d) dealing with complaints;
(e) implementation and verification of corrective and preventive actions;
(f) the purchase and receipt of consignments of materials (e.g. samples, reagents);
(g) the procurement, preparation and control of reference substances and reference materials (8);
(h) the internal labelling, quarantine and storage of materials;
(i) the qualification of equipment (11);
(j) the calibration of equipment;
(k) preventive maintenance and verification of instruments and equipment;
(l) sampling, if performed by the laboratory, and visual inspection;
(m) the testing of samples with descriptions of the methods and equipment used;
(n) atypical and OOS results;
(o) validation of analytical procedures;
(p) cleaning of laboratory facilities, including bench tops, equipment, work stations, clean rooms (aseptic suites) and glassware;
(q) monitoring of environmental conditions, e.g. temperature and humidity;
(r) monitoring storage conditions;
(s) disposal of reagents and solvent samples; and
(t) safety measures.
SOPs (2)
Reference substances and reference materials - procurement, preparation and control
Internal labelling, quarantine and storage of materials
Qualification, calibration and verification of equipment
Preventive maintenance
Sampling, and testing of samples, atypical and OOS results
Validation of analytical procedures
2.3 The laboratory should establish, implement and maintain authorized written SOPs including, but not limited to, administrative and technical operations, such as:
(a) personnel matters, including qualifications, training, clothing and hygiene;
(b) the change control;
(c) internal audit;
(d) dealing with complaints;
(e) implementation and verification of corrective and preventive actions;
(f) the purchase and receipt of consignments of materials (e.g. samples, reagents);
(g) the procurement, preparation and control of reference substances and reference materials (8);
(h) the internal labelling, quarantine and storage of materials;
(i) the qualification of equipment (11);
(j) the calibration of equipment;
(k) preventive maintenance and verification of instruments and equipment;
(l) sampling, if performed by the laboratory, and visual inspection;
(m) the testing of samples with descriptions of the methods and equipment used;
(n) atypical and OOS results;
(o) validation of analytical procedures;
(p) cleaning of laboratory facilities, including bench tops, equipment, work stations, clean rooms (aseptic suites) and glassware;
(q) monitoring of environmental conditions, e.g. temperature and humidity;
(r) monitoring storage conditions;
(s) disposal of reagents and solvent samples; and
(t) safety measures.

SOPs

Cleaning of laboratory facilities, including bench tops, equipment, work stations, clean rooms (aseptic suites) and glassware
Monitoring of environmental conditions, e.g. temperature and humidity
Monitoring storage conditions
Disposal of reagents and solvent samples; and
Safety measures
2.3 The laboratory should establish, implement and maintain authorized written SOPs including, but not limited to, administrative and technical operations, such as:
(a) personnel matters, including qualifications, training, clothing and hygiene;
(b) the change control;
(c) internal audit;
(d) dealing with complaints;
(e) implementation and verification of corrective and preventive actions;
(f) the purchase and receipt of consignments of materials (e.g. samples, reagents);
(g) the procurement, preparation and control of reference substances and reference materials (8);
(h) the internal labelling, quarantine and storage of materials;
(i) the qualification of equipment (11);
(j) the calibration of equipment;
(k) preventive maintenance and verification of instruments and equipment;
(l) sampling, if performed by the laboratory, and visual inspection;
(m) the testing of samples with descriptions of the methods and equipment used;
(n) atypical and OOS results;
(o) validation of analytical procedures;
(p) cleaning of laboratory facilities, including bench tops, equipment, work stations, clean rooms (aseptic suites) and glassware;
(q) monitoring of environmental conditions, e.g. temperature and humidity;
(r) monitoring storage conditions;
(s) disposal of reagents and solvent samples; and
(t) safety measures.
Laboratory activities systematically and periodically audited (internally and, where appropriate, by external audits or inspections) to verify compliance  - CAPA
Audits by trained and qualified personnel
Planning and organizing internal audit
Regular management review (e.g. annually) to cover e.g.
audit or inspection reports
investigations  (complaints, atypical results) and CAPAs
2.4 The activities of the laboratory should be systematically and periodically audited (internally and, where appropriate, by external audits or inspections) to verify compliance with the requirements of the quality management system and to apply corrective and preventive actions, if necessary. The audits should be carried out by trained and qualified personnel, who are independent of the activity to be audited. The quality manager is responsible for planning and organizing internal audits addressing all elements of the quality management system. Such audits should be recorded, together with details of any corrective and preventive action taken.

2.5 Management review of quality issues should be regularly undertaken (at least annually), including:
(a) reports on internal and external audits or inspections and any follow-up required to correct any deficiencies;
(b) the outcome of investigations carried out as a result of complaints received, doubtful (atypical) or aberrant results reported in collaborative trials and/or proficiency tests; and
(c) corrective actions applied and preventive actions introduced as a result of these investigations.

4.4 Quality management records should include reports from internal (and external if performed) audits and management reviews, as well as records of all complaints and their investigations, including records of possible corrective and preventive actions.

Records

Procedure for the identification, collection, indexing, retrieval, storage, maintenance and disposal of documents/records
All original observations, calculations and derived data, calibration, validation and verification records, etc. and final results must be retained on record for an appropriate period of time, e.g.
whole length of time the drug is on the market
Records to contain sufficient information to permit repetition of tests and traceability

Records


4.1 The laboratory should establish and maintain procedures for the identification, collection, indexing, retrieval, storage, maintenance and disposal of and access to all quality and technical/scientific records.

4.2 All original observations, including calculations and derived data, calibration, validation and verification records and final results, should be retained on record for an appropriate period of time in accordance with national regulations and, if applicable, contractual arrangements, whichever is longer. The records should include the data recorded in the analytical worksheet by the technician or analyst on consecutively numbered pages with references to the appendices containing the relevant recordings, e.g. chromatograms and spectra. The records for each test should contain sufficient information to permit the tests to be repeated and/or the results to be recalculated, if necessary. The records should include the identity of the personnel involved in the sampling, preparation and testing of the samples. The records of samples to be used in legal proceedings should be kept according to the legal requirements applicable to them.

Note: The generally accepted retention period of shelf-life plus one year for a pharmaceutical product on the market and 15 years for an investigational product is recommended, unless national regulations are more stringent or contractual arrangements do not require otherwise.

Records must be:

Legible, readily retrievable, stored and retained
In a suitable environment that will prevent modification, damage or deterioration and/or loss
Secure, confidential. Access restricted to authorized personnel.
Electronic storage and signatures allowed - restricted access and in conformance with requirements for electronic records
4.3 All quality and technical/scientific records (including analytical test reports, certificates of analysis and analytical worksheets) should be legible, readily retrievable, stored and retained within facilities that provide a suitable environment that will prevent modification, damage or deterioration and/or loss. The conditions under which all original records are stored should be such as to ensure their security and confidentiality and access to them should be restricted to authorized personnel. Electronic storage and signatures may also be employed but with restricted access and in conformance with
requirements for electronic records (12–16).
Data processing equipment

Includes computers, automated tests or calibration equipment;

used for collection, processing, recording, reporting, storage or
retrieval of test and/or calibration data
See recommendations in Appendix 5 to Annex 4 of the Fortieth report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations: Supplementary guidelines in good manufacturing practice: validation. Validation of computerized systems (12)
Where used, requires systematic verifications of calculations and data transfers
5. Data-processing equipment

5.1 Detailed recommendations are provided in Appendix 5 to Annex 4 of the Fortieth report of the WHO Expert Committee on Specifications for Pharmaceutical Preparations: Supplementary guidelines in good manufacturing practice: validation. Validation of computerized systems (12).
Software is documented and appropriately validated or verified
Procedures are established and implemented for protecting the integrity of data
confidentiality of data entry or collection
storage, transmission and processing
access control, and audit trail
Maintenance  and an appropriate environment
Change control
Back up (intervals, retrievable, storage, no data loss).

5.2 For computers, automated tests or calibration equipment, and the collection, processing, recording, reporting, storage or retrieval of test and/or calibration data, the laboratory should ensure that:

(a) computer software developed by the user is documented in sufficient detail and appropriately validated or verified as being suitable for use;
 (b) procedures are established and implemented for protecting the integrity of data. Such procedures should include, but are not limited to, measures to ensure the integrity and confidentiality of data entry or collection and the storage, transmission and processing of data. In particular, electronic data should be protected from unauthorized access and an audit trail of any amendments should be maintained;
(c) computers and automated equipment are maintained so as to function properly and are provided with the environmental and operating conditions necessary to ensure the integrity of test and calibration data;
(d) procedures are established and implemented for making, documenting and controlling changes to information stored in computerized systems; and
(e) electronic data should be backed up at appropriate regular intervals according to a documented procedure. Backed-up data should be retrievable and stored in such a manner as to prevent data loss.

Note: For further guidance on validation of data-processing equipment, refer to documents published by the International Society for Pharmaceutical Engineering (13, 14), US Food and Drug Administration (15), European Commission (16) and the Official Medicines Control Laboratories Network of the Council of Europe (17).

- Personnel
- Sufficient personnel  with job descriptions and records proving appropriate education, training, technical knowledge and experience
- Ensure the competence of all personnel
- Staff undergoing training should be appropriately supervised and should be assessed on completion of the training.
- Permanent employees or contract workers
- Contract workers are trained and know the QMS

Personnel


6.1 The laboratory should have sufficient personnel with the necessary education, training, technical knowledge and experience for their assigned functions.

6.2 The technical management should ensure the competence of all personnel operating specific equipment, instruments or other devices, who are performing tests and/or calibrations, validations or verifications. Their duties also involve the evaluation of results as well as signing analytical test reports and certificates of analysis (see Part three, sections 18.7–18.11 and 19).

6.3 Staff undergoing training should be appropriately supervised and should be assessed on completion of the training. Personnel performing specific tasks should be appropriately qualified in terms of their education, training and experience, as required.

6.4 The laboratory personnel should be permanently employed or under contract. The laboratory should ensure that additional technical and key support personnel who are under contract are supervised and sufficiently competent and that their work is in accordance with the quality management system.

6.5 The laboratory should maintain current job descriptions for all personnel involved in tests and/or calibrations, validations and verifications. The laboratory should also maintain records of all technical personnel, describing their qualifications, training and experience.

Managerial and technical personnel:
Head of laboratory (supervisor)
Technical managers
Analysts

Technical staff

6.6 The laboratory should have the following managerial and technical personnel:
(a) a head of laboratory (supervisor), who should have qualifications appropriate to the position, with extensive experience in medicines analysis and laboratory management in a pharmaceutical quality control laboratory in the regulatory sector or in industry. The head of laboratory is responsible for the content of certificates of analysis and analytical testing reports. This person is also responsible for ensuring that:
(i) all key members of the laboratory staff have the requisite competence for the required functions and their grades reflect their responsibilities,
(ii) the adequacy of existing staffing, management and training procedures is reviewed periodically,
(iii) the technical management is adequately supervised;
(b) the technical management who ensure that:
(i) procedures for performing calibration, verification and (re-) qualification of instruments, monitoring of environmental and storage conditions are in place and are conducted as required,
(ii) regular in-service training programmes to update and extend the skills of both professionals and technicians are arranged,
(iii) the safekeeping of any materials subject to poison regulation or to the controls applied to narcotic and psychotropic substances (see Part one, section 7.12) kept in the workplace is under the supervision of an authorized person,
(iv) national pharmaceutical quality control laboratories regularly participate in suitable proficiency testing schemes and collaborative trials to assess analytical procedures or reference substances;
(c) analysts, who should normally be graduates in pharmacy, analytical chemistry, microbiology or other relevant subjects, with the requisite knowledge, skills and ability to adequately perform the tasks assigned to them by management and to supervise technical staff;
(d) technical staff, who should hold diplomas in their subjects awarded by technical or vocational schools; and (e) a quality manager (see Part one, section 1.3(j)).
The Head of laboratory  should have extensive experience in medicine analysis and laboratory management.

Responsibilities/functions include:

All key staff have the requisite competence
Periodic review of adequacy of existing staffing, management, and training procedures
Ensuring technical management is supervised
The head of laboratory is responsible for the content of certificates of analysis and analytical testing reports. This person is also responsible for ensuring that:
(i) all key members of the laboratory staff have the requisite competence for the required functions and their grades reflect their responsibilities,
(ii) the adequacy of existing staffing, management and training procedures is reviewed periodically,
(iii) the technical management is adequately supervised;
Technical management  to ensure that:
Procedures are in place and implemented:
calibration, verification and (re-) qualification of instruments, monitoring of environmental and storage conditions

Training programs are current

Materials are kept (also poisons and narcotic and psychotropic substances  under the supervision of an authorized person
Participation in proficiency testing schemes and collaborative trials where appropriate
(b) the technical management who ensure that:
(i) procedures for performing calibration, verification and (re-) qualification of instruments, monitoring of environmental and storage conditions are in place and are conducted as required,
(ii) regular in-service training programmes to update and extend the skills of both professionals and technicians are arranged,
(iii) the safekeeping of any materials subject to poison regulation or to the controls applied to narcotic and psychotropic substances (see Part one, section 7.12) kept in the workplace is under the supervision of an authorized person,
(iv) national pharmaceutical quality control laboratories regularly participate in suitable proficiency testing schemes and collaborative trials to assess analytical procedures or reference substances;

Analysts and technical staff:

- Analysts should be qualified in e.g. pharmacy, analytical chemistry, microbiology or other relevant subjects, have knowledge, skills and ability to do the work
- Technical staff should hold diplomas in their subjects awarded by technical or vocational schools

Quality manager to ensure compliance with the quality management system

(c) analysts, who should normally be graduates in pharmacy, analytical chemistry, microbiology or other relevant subjects, with the requisite knowledge, skills and ability to adequately perform the tasks assigned to them by management and to supervise technical staff;
(d) technical staff, who should hold diplomas in their subjects awarded by technical or vocational schools; and
(e) a quality manager (see Part one, section 1.3(j)).

Premises

Suitable size, construction and location – appropriate for the functions and operations
Instruments and equipment, work benches, work stations and fume hoods
Separate rest and refreshment rooms, changing areas and toilets
Adequate safety equipment  and good housekeeping
Environmental conditions (lighting, energy, temperature, humidity, air pressure) - monitored, controlled and documented

Premises 

7.1 The laboratory facilities are to be of a suitable size, construction and location. These facilities are to be designed to suit the functions and operations to be conducted in them. Rest and refreshment rooms should be separate from laboratory areas. Changing areas and toilets should be easily accessible and appropriate for the number of users.

7.2 The laboratory facilities should have adequate safety equipment located appropriately and measures should be in place to ensure good housekeeping. Each laboratory should be equipped with adequate instruments and equipment, including work benches, work stations and fume hoods.

7.3 The environmental conditions, including lighting, energy sources, temperature, humidity and air pressure, are to be appropriate to the functions and operations to be performed. The laboratory should ensure that the environmental conditions are monitored, controlled and documented and do not invalidate the results or adversely affect the quality of the measurements.

7.4 Special precautions should be taken and, if necessary, there should be a separate and dedicated unit or equipment (e.g. isolator, laminar flow work bench) to handle, weigh and manipulate highly toxic substances, including genotoxic substances. Procedures should be in place to avoid exposure and contamination.

Premises

- Suitable archive facilities - protect and prevent deterioration. Access controlled
- Highly toxic substances - special precautions such as separate and dedicated unit or equipment (e.g. isolator, laminar flow work bench)
- Microbiological testing (see separate WHO guideline)
- In vivo biological testing – separate
- Waste removal including toxic waste

7.4 Special precautions should be taken and, if necessary, there should be a separate and dedicated unit or equipment (e.g. isolator, laminar flow work bench) to handle, weigh and manipulate highly toxic substances, including genotoxic substances. Procedures should be in place to avoid exposure and contamination.

7.5 Archive facilities should be provided to ensure the secure storage and retrieval of all documents. The design and condition of the archives should be such as to protect the contents from deterioration. Access to the archives should be restricted to designated personnel.

7.6 Procedures should be in place for the safe removal of types of waste including toxic waste (chemical and biological), reagents, samples, solvents and air filters.

7.7 Microbiological testing, if performed, should be contained in an appropriately designed and constructed laboratory unit. For further guidance see the draft working document WHO guideline on good practices for pharmaceutical microbiology laboratories (reference QAS/09.297).

7.8 If in vivo biological testing (e.g. rabbit pyrogen test) is included in the scope of the laboratory activities then the animal houses should be isolated from the other laboratory areas with a separate entrance and air-conditioning system. The relevant guidance and regulations are to be applied.

Laboratory storage facilities

 Well organized for the correct storage of samples, reagents and equipment. – locked and access controlled
Separate areas for samples, retained samples, reagents and laboratory accessories, reference substances and reference materials
Provision for  refrigeration (2–8°C) and frozen (-20°C). Controlled, monitored and recorded.
Safety procedures for storage of toxic or flammable reagents

Laboratory storage facilities

7.9 The storage facilities should be well organized for the correct storage of samples, reagents and equipment.

7.10 Separate storage facilities should be maintained for the secure storage of samples, retained samples (see Part three, section 20), reagents and laboratory accessories (see Part two, sections 10.13– 10.14), reference substances and reference materials (see Part two, section 11). Storage facilities should be equipped to store material, if necessary, under refrigeration (2–8°C) and frozen (-20°C) and securely locked. All specified storage conditions should be controlled, monitored and records maintained. Access should be restricted to designated personnel.

7.11 Appropriate safety procedures should be drawn up and rigorously implemented wherever toxic or flammable reagents are stored or used. The laboratory should provide separate rooms or areas for storing flammable substances, fuming and concentrated acids and bases, volatile amines and other reagents, such as hydrochloric acid, nitric acid, ammonia and bromine. Self-igniting materials, such as metallic sodium and potassium, should also be stored separately. Small stocks of acids, bases and solvents may be kept in the laboratory store but the main stocks of these items should preferably be retained in a store separate from the laboratory building.

7.12 Reagents subject to poison regulations or to the controls applied to narcotic and psychotropic substances should be clearly marked as required by national legislation. They should be kept separately from other reagents in locked cabinets. A designated responsible member of staff should maintain a register of these substances. The head of each unit should accept personal responsibility for the safekeeping of any of these reagents kept in the workplace.

7.13 Gases also should be stored in a dedicated store, if possible isolated from the main building. Wherever possible gas bottles in the laboratory are to be avoided and distribution from an external gas store is preferred. If gas bottles are present in the laboratory they should be safely secured.

Note: Consideration should be given to the installation of gas generators.

Laboratory storage facilities (2)

- Poisons, narcotic and psychotropic substances clearly marked
- Kept separately in locked cabinets.
- Designated responsible person to maintain a register
- Gases stored in a dedicated store, if possible isolated from the main building.
- Gas bottles avoided in the laboratory or safely secured.

Note: Consider  installation of gas generators.

Laboratory storage facilities

7.12 Reagents subject to poison regulations or to the controls applied to narcotic and psychotropic substances should be clearly marked as required by national legislation. They should be kept separately from other reagents in locked cabinets. A designated responsible member of staff should maintain a register of these substances. The head of each unit should accept personal responsibility for the safekeeping of any of these reagents kept in the workplace.

7.13 Gases also should be stored in a dedicated store, if possible isolated from the main building. Wherever possible gas bottles in the laboratory are to be avoided and distribution from an external gas store is preferred. If gas bottles are present in the laboratory they should be safely secured.

Note: Consideration should be given to the installation of gas generators.

- Equipment, instruments and other devices
- Laboratory should have necessary equipment
- Meet requirements and specifications
- Designed, constructed, adapted, located, calibrated, qualified, verified and maintained
- Purchased from agents capable of providing full technical support and maintenance when necessary

8. Equipment, instruments and other devices

8.1 Equipment, instruments and other devices should be designed, constructed, adapted, located, calibrated, qualified, verified and maintained as required by the operations to be carried out in the local environment. The user should purchase the equipment from an
agent capable of providing full technical support and maintenance when necessary.

8.2 The laboratory should have the required test equipment, instruments and other devices for the correct performance of the tests and/or calibrations, validations and verifications (including the preparation of samples and the processing and analysis of test and/or calibration data).

8.3 Equipment, instruments and other devices, including those used for sampling, should meet the laboratory’s requirements and comply with the relevant standard specifications, as well as being verified, qualified and/or calibrated regularly (see Part two, section 12).

Contracts

Purchasing services and supplies
Procedure for the selection and purchasing of services and supplies
Evaluate suppliers of critical consumables, supplies and services which affect quality of testing - maintain records
Approved suppliers list 

Contracts

Purchasing services and supplies

9.1 The laboratory should have a procedure for the selection and purchasing of services and supplies it uses that affect the quality of testing.

9.2 The laboratory should evaluate suppliers of critical consumables, supplies and services which affect quality of testing, maintain records of these evaluations and list approved suppliers, which have been demonstrated to be of a suitable quality with respect to the requirements of the laboratory.

Subcontracting of testing

- Subcontracting - in writing and, with approval
- Written contract with duties and responsibilities of each party
- Use organizations approved for the type of activity required
- Periodic assessment of the competence of contracted organization
- No delegation to a third party without  prior evaluation and approval
- Register of all subcontractors
- Subcontracting of testing

9.3 When a laboratory subcontracts work, which may include specific testing, it is to be done with organizations approved for the type of activity required. The laboratory is responsible for periodically assessing the competence of a contracted organization.

9.4 When a laboratory performs testing for a customer and subcontracts part of the testing, it should advise the customer of the arrangement in writing and, if appropriate, gain his or her approval.

9.5 There should be a written contract which clearly establishes the duties and responsibilities of each party, defines the contracted work and any technical arrangements made in connection with it. The contract should permit the laboratory to audit the facilities and competencies of the contracted organization and ensure the access of the laboratory to records and retained samples.

9.6 The contracted organization should not pass to a third party any work entrusted to it under contract without the laboratory’s prior evaluation and approval of the arrangements.

9.7 The laboratory should maintain a register of all subcontractors that it uses and a record of the assessment of the competence of subcontractors.

9.8 The laboratory takes the responsibility for all results reported, including those furnished by the subcontracting organization.

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