1. A SEMINAR ON GOOD
MANUFACTURING PRACTICES
FOR ORGANIZATION AND
PERSONNEL
GUIDED BY: PRESENTED BY:
Mr. Moin K. Modasiya Hitiksha Kanani
M.PHARM (Q.A.)
SEM - 1
APMC College Of Pharmaceutical Education And
Research, Motipura, Himatnagar

2. CONTENTS
 ORGANIZATION
 Introduction
 Responsibilities
 Authorities
 PERSONNEL
 Objectives
 Principle
 General
 Key personnel
 Qualification of personnel
 Different stages of training
 Personnel responsibilities
 Personnel hygiene
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3. ORGANIZATION
Compliance
 Policies and Standards Audit (Internal and External).
 Regulatory Commitments and Documents.
 Recall.
 In the above model, the three groups typically report to one quality
head or leader. The activities and responsibilities in QA and
compliance can vary, and in smaller organizations, there may be
only a QA and QC organization.
 QC: All inspection & testing.
QA: All systems and procedures including batch review and audit.
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4. ORGANIZATION
 ROLE OF QA AND QC UNITS :
 QA role is critical because of gaining importance with increased
reliance on non-QC personnel for quality related activity such as
in-process control and customer complaint co-ordination.
 QC should be a resource that plays a positive role in improving
profitability.
 More effective approaches should be as following :
 Design quality during development phase.
 Subsequently adding additional assurance during production.
 New product –developed by R&D team they should provide
draft with appropriate specifications then, reviewed &
approved by QC.
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5. ORGANIZATION
Reporting
 Can not report to the person directly accountable for the production.
 This creates pressure on production.
In some companies:
1. Reporting to the group QC function/ scientific / technical
function.
2. Reporting to plant manager provides.
 This gives an added degree of independence.
 Quality can not be achieved by police approach.
Ideal:
Entire plant operate as a quality-aware team.
Every person should perform his job to achieve standards.
With independent QC,responsibility is divided for production& QC.
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6. ORGANIZATION
Authority & Responsibility of QC
To reject or approve
 All components;
 Drug product containers;
 Closures;
 In-process materials;
 Packaging materials;
 Labeling;
 Drug products; to review production records to assure
that no errors have occurred.
Availability of adequate laboratory facilities for (all in one).
Responsibility (Authority): Approve all procedures and
specifications impacting on identification, strength, quality and
purity of the drug product.
Responsibilities and procedures as written procedures.
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7. ORGANIZATION

8. PERSONNEL
Objectives:
 To review general issues related to personnel.
 To review requirements for key personnel.
 To review the training of personnel.
 To consider some specific issues.

9. PERSONNEL
Principle:
 Establishment and maintenance of satisfactory system of
QA, manufacture and control of products and active
ingredients rely on people.
 Must be sufficient qualified personnel to carry out tasks.
 Individual responsibilities must be clearly defined and
understood by individuals concerned.
 Written job descriptions and all personnel should be aware
of the principles of GMP that affect them.

10. PERSONNEL
General (a):
Personnel requirements:
 Adequate number of persons.
 With necessary qualifications.
 With practical experience.
 An individual’s responsibilities should not be so extensive
as to present a risk to quality.

11. PERSONNEL
General (b):
 All responsible staff should have specific duties recorded
in individual written job descriptions.
 Have adequate authority to carry out responsibilities.
 May delegate to designated deputies with qualifications.
 No gaps or unexplained overlaps.
 Organization chart.

12. PERSONNEL
General (c):
 All personnel should be aware of GMP.
 Must receive training in GMP:
 Initial training.
 Continuing training.
 Including hygiene standards.
 Motivated to
 Support the establishment.
 Maintain high-quality standards.

13. PERSONNEL
Key Personnel:
Key personnel (which normally should be full-time)
positions include:
 Authorized person.
 Head of Production.
 Head of Quality Control.
 May delegate functions – not responsibility.
 Heads of Production and Quality Control should be
independent of each other.

14. PERSONNEL
Head of Production: Responsibilities
 Product production and storage according to appropriate
documentation.
 Approval and implementation of production instructions,
in-process QC and ensure strict implementation.
 Ensures that production records are evaluated and
signed by designated person.
 Checks maintenance of production department, premises
and equipment.
 Ensures initial and continuous training of production
personnel.

15. PERSONNEL
Head of Quality Control: Responsibilities
 Approval or rejection of materials, e.g. packaging materials,
intermediates, bulk and finished products, in accordance with
specifications.
 Evaluation of batch records.
 Ensures carrying out of necessary testing.
 Approval of quality control procedures, e.g. sampling and testing;
specifications.
 Approval and monitoring of all contract analysis.
 Ensures validation (including analytical procedure validation)
and calibration of control equipment.

16. PERSONNEL
Authorized person: Responsibilities
 Oversight of the QC department.
 Participation in external audits and vendor audits.
 Participation in validation programmes.
 May delegate approval of release of product through
approved procedure.
 Normally by QA by means of batch review.

17. PERSONNEL
Qualifications:
Should posses appropriate qualifications.
 Scientific education such as:
 Chemistry or biochemistry;
 chemical engineering;
 microbiology;
 pharmaceutical sciences and technology;
 pharmacology and toxicology;
 physiology; or
 other related science subjects relevant to the responsibilities to
be undertaken.

18. PERSONNEL
Should posses appropriate experience
 Practical experience
 Manufacture and quality assurance.
 Preparatory period under professional guidance
sometimes needed.
 Education and experience should enable personnel to take
difficult decisions in an independent, professional and
scientific way
 Resolve the problems encountered in manufacturing
and QC.

19. TRAINING
At all levels a developing and continuous process where
performance and appraisal.
FDA (cGMP): no definition of education qualification, experience,
skill, knowledge.
However, European and WHO guidelines specify education
qualification ,experience, skill, and knowledge both production and
quality.
Initial screening
Selection of persons with basic skills
 Reading: to follow written procedure;
 Writing: for recording atypical situations;
 Numeracy: for statistical process controls;
 No color vision problem.
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20. TRAINING & DEVELOPMENT CYCLE
Basic
Position Applicant Induction training
requirements screening training
defined
Evaluation
& appraisal
New position
Additional
/retraining
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21. TRAINING INDIAN GMP
Training programmed include:
 Principles of GMP and Principles of GLP.
 Duties & responsibilities of different personnel.
 Cleanliness, general hygiene, personal Cleanliness, and health.
 Characteristics of pharmaceuticals , handling & dangers.
 First aid and Fire fighting & other safety measures.
 Topics like behavioral sciences.
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22. TRAINING
Appropriate evaluation steps are required at the end of each
module followed by appraisal ( to confirm the learned lessons are
put into practice).
Repetition of training is required if necessary.
Regular evaluation / appraisal decides that level of employee.
 Further need of training or to meet the changing needs of the
situation or preparation for a new job.
 Training is under handling of departmental management.
 Training records must be maintained.
 Review of training content & records is also needed.
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23. PERSONNEL RESPONSIBILITIES
 Related to personnel hygiene
Any person engaged in following jobs like
 Manufacturing ;
 Processing ;
 Packaging ;
 Holding of a drug ; should wear clean clothing.
Protective apparel
Limited access areas : restricted movements.
Illness/ any visible lesions: affect the quality of the product such
persons are excluded from direct contact with components, drug
product containers, closures, in-process materials.
All persons : report to supervising personnel.
Appropriate clothing : considering the end purpose of quality of product.
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24. PERSONNEL RESPONSIBILITIES
Wearing plant uniforms: satisfactory
Guidelines
 Sufficient amount of clean uniforms: frequency of clean.
 Checking washing and sanitation processes for effectiveness.
 Special Clean areas: wear only lint free garments.
 Designing & type of clothing: for maximum comfort.
 Range of clothing:
1. Hats/hair cover;
2. Coveralls;
3. Disposable gloves;
4. Foot cover;
5. Masks;
6. Safety glasses/goggles;
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25. PERSONNEL HYGIENE
Medical history:
Pre employment medical examination is required.
Chest X-ray, Wassermann test, tuberculosis test, periodic eye test.
Fitness certificate is necessary after illness.
Annual medical examination of personnel is also required.
Main Objective:
 To protect the product from personnel and particulate matter.
 To prevent contamination.
Consultants: advising, sufficient education, experience,
Records are to be maintained.
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26. REFERENCES
 Willig H. Sidney, Stoker R. James; “Good manufacturing practices
for pharmaceuticals”, Marcel Dekker series Volume-78, Fourth
edition, p.p. 23-31.
 P.P. Sharma; “How to practice GMPs”, Vandana Publication,
Fourth edition,p.p.149-160.
 http://pharmatips.doyouknow.in/Articles/Quality-
Assurance/GMP/GMP-Organization-And- Personnel.aspx
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