The document outlines the importance of a robust quality assurance system in pharmaceutical manufacturing, emphasizing that qualified personnel are crucial for achieving product quality, safety, and efficacy. It details the roles and responsibilities of key personnel, including the Head of Production (HOP), Head of Quality Control (HOQC), and Authorized Person, along with the necessary qualifications and training for effective operations. Furthermore, it highlights the significance of hygiene practices, training protocols, and maintaining comprehensive personnel records to ensure compliance with Good Manufacturing Practices (GMP).

1. UNIT II – CHAPT 1
Ms. TENY SARA THOMAS
MOUNT ZION COLLEGE OF
PHARMACEUTICAL SCIENCES
AND RESEARCH, ADOOR,
KERALA
ASSISTANT PROFESSOR
B.PHARM SIXTH SEMESTER
PHARMACEUTICAL QUALITY
ASSURANCE
ORGANISATION & PERSONNEL

2. INTRODUCTION
• In the complex field of pharmaceutical
manufacturing, it is important to have a sound quality
system in place to make sure that products
manufactured have the desired quality, safety and
efficacy.
• At the same time, it is vital to recognise that even the
best quality system is only as good as the people who
make it work.
• Personnel are the backbone of the manufacturing
unit, and there must be a sufficient number of
adequately qualified and trained staff to ensure one
achieves the desired quality product.

3. • It is important to lay out individual responsibilities in a
manner that is clear enough to be understood by the personnel
who are to perform the respective tasks. Written job
descriptions must be available and an organisational chart
must be prepared to show the hierarchical organisation of
employees.
• All personnel should be aware of the principles of Good
Manufacturing Practice that affect them and receive initial
and continuing training, including hygiene instructions,
relevant to their needs.
• People in responsible positions should have specific duties
recorded in written job descriptions and adequate authority to
carry out their responsibilities.
• There should be no gaps or unexplained overlaps in the
responsibilities of those personnel concerned with the
application of Good Manufacturing Practice

4. HIERARCHICAL ORGANISATION OF
EMPLOYEES

5. KEY
PERSONNEL

6. KEY PERSONNEL
Key Personnel of an Organisation include:-
• Head of Production (HoP)
• Head of Quality Control (HoQC)
• Authorized Person
The Head of Production and Head of Quality Control
should be independent of each other.
Key personnel responsible for supervising the
manufacturing and quality control of pharmaceutical
products should possess qualifications of a scientific
education and practical experience required by national
legislation. Their education should include any degree
in a scientific field or pharmaceutical field.

7. The HoP and HoD share or jointly exercise responsibilities:-
• Authorization of written procedures and other documents.
•Monitoring and control of manufacturing environment.
•Plant hygiene.
•Process validation and calibration of analytical instruments
•Training.
•Approval and monitoring of suppliers of materials and
contact manufacturers.
•Retention of records.
•Designation and monitoring of storage conditions.
•Monitoring of compliance with GMP.
•Inspection, investigation, and taking of samples in order to
monitor facts that may affect product quality.

8. HEAD of PRODUCTION (HoP)
• To ensure that products are produced and stored according to the
appropriate documentation in order to obtain the required
quality.
• To approve the instructions relating to production operations and
to ensure their strict implementation.
• To ensure that the production records are evaluated and signed
by an designated person before they are sent to the Quality
Control Department.
• To check the maintenance of his department,
premises and equipment.
• To ensure that appropriate process validations and calibrations
of control equipment are performed and recorded and reports are
made available.
• To ensure that the required initial and continuing training of
production personnel is carried out.

9. HEAD of QUALITY CONTROL (HoQC)
• To approve or reject, as he sees fit,
starting materials, packaging materials and intermediate ,
bulk and finished products
• To evaluate batch records
• Ensure all testing is carried out
• Approve sampling instructions, specifications, test
methods, and other quality control procedures.
• Approve and monitor analyses carried out
• Check the maintenance of the department, premises and
equipment.
• Ensure that the appropriate validations and calibrations of
control equipment
• Ensure that required initial and continuing training of
quality control personnel is carried out.

10. AUTHORIZED PERSON
• Responsible for compliance with technical and
regulatory requirements related to quality of finished
products
• Implementation of the quality system
• Participation in the development of company's quality
manual
• Supervision of regular internal audits
• Oversight of QC department
• Participation in external audit
• Participation in validation programmes

11. APPROVAL & RELEASE OF FINISHED PRODUCT
• Personnel responsible, should have appropriate
qualifications and experience
• Marketing and manufacturing authorization requirements
should be met by the finished product.
• Ensure that principles and guidelines of GMP are followed.
• The principal manufacturing and testing processes have
been validated.
• Ensures all necessary checks and tests have been performed
• Any planned changes in manufacturing or quality control
have been notified
• Any additional sampling, inspection, tests and checks have
been carried out.
• Ensure appropriate audits, self inspections and spot checks
are carried out by experienced and trained staff.

12. RESPONSIBILITIES OF A PERSONNEL
The guidelines for personnel responsibilities in the work
area:-
• Personnel involved in aseptic manufacturing, processing,
packaging, and handling of drug products should wear clean
clothing or uniform.
• They should wear protective apparels, such as coverings for
head, face, hands, and arms to prevent contamination of the
drug products.
• The company should provide appropriate uniforms or
protective clothing to the personnel. If protective clothing
needed, personnel should be trained in donning and removing
the protective clothing.
• Personnel should follow good sanitation and healthy habits.

13. • Should not wear jewellery or make up in
production / QC areas because it can result in
safety hazard and a contamination issue.
• Eating, drinking, chewing, smoking should be
restricted in production and storage areas.
• Only authorized and trained personnel should
be allowed to enter the production and other
areas. Also the entry should be limited.
• A personnel should be physically fit to work,
routine medical check up and physical fitness
test should be done by the company.
• If an individual found to have an illness or
open lesions that may adversely effect the
safety of quality of drug product, report to
the supervisor regarding any health
issues.

14. PERSONNEL
TRAINING

15. • The manufacturer should provide training for all the
personnel whose duties take them into production
areas or into control laboratories (including the
technical, maintenance and cleaning personnel),
and for other personnel whose activities could affect
the quality of the product.
• Newly recruited personnel should receive training
appropriate to the duties assigned to them.
Continuing training should also be given.
• Training records should be kept.

16. • Personnel working in areas where contamination is
a hazard, e.g. clean areas or areas where highly
active, toxic, infectious or sensitizing materials are
handled, should be given specific training.
• Visitors or untrained personnel should, preferably,
not be taken into the production and quality control
areas. If this is unavoidable, they should be given.
• Information in advance, particularly about personal
hygiene and the prescribed protective clothing.
They should be closely supervised.

17. Job Description
Training
Requirement Individual training
plan
Appropriate Training
events
Documentation
Approved and
Accurate Training
Material
Evaluation
Qualified trainer
Knowledgeable
training designer

18. TRAINING SYSTEM
• An accurate description of the Job or role.
• Specific training of job or role
• Training plan to be completed.
• Training material
• Qualified trainers
• Post training evaluation to measure the effectiveness of
the training.
• Documentation and book keeping system.

19. TRAINING PLAN
Training plan should be designed and implemented
in such a way that each individual receives right training at
right time. Training plan should include the following-
Training topic
Mode of Training
Sequence of training
Approximate time of training
Indication when the individual is trained.

20. PERSONNEL
HYGIENE

21. • All personnel should undergo health examinations
• Undergo periodic eye examinations
• Trained in practice of personal hygiene
• Instructed to wash hands before entering production
areas.
• If an individual found to have an illness or open lesions
that may adversely effect the safety of quality of drug
product, should not be allowed to handle starting,
packaging, in-process materials or drug products.
• All employees should be instructed to report to the
immediate supervisor.
• To ensure protection form contamination, wear clean
body coverings, appropriate to their duties.

22. • Reusable clothes should be stored in separate closed
containers until properly laundered, and if necessary
disinfected and sterilized.
• Personnel should be instructed to use the hand washing
facilities.
• Direct contact should be avoided between the operators
hands and exposed products as well as with any part of
the equipment that comes into contact with the
products.
• Avoid cosmetics such as face powder, hair sprays,
perfumes and aftershave.

23. PERSONNEL
RECORDS

24. • Personnel records are records pertaining to employees
of an organisation.
• These records are accumulated, factual, and
comprehensive information related to concern records
and detained.
• All information with effect to human resources in the
organisation is kept in a systematic order. Such records
are helpful to a manager in various decision making
areas.
• Keep an update record of leaves, transfers, turnover etc
• Helps researchers to carry in-depth study with respect to
industrial relations and goodwill of the firm in the
market.
• Personal Records include:- employment records,
training records, health records, miscellaneous etc.,