PHARMACEUTICAL QUALITY ASSURANCE

Teacher

Mr. HARA GOURI MISHRA

Category

Core Courses

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Course Name: Pharmaceutical Quality Assurance

Course Code(Credit): BPHT3206(4-0-0)

Course Objectives

This course deals with the various aspects of quality control and quality
assurance aspects of pharmaceutical industries. It deals with the important aspects like cGMP, QC tests, documentation, quality certifications and regulatory affairs.

Learning Outcomes

Upon completion of the course student shall be able to:

  1. Understand the cGMP aspects in a pharmaceutical industry
  2. Appreciate the importance of documentation
  3. Understand the scope of quality certifications applicable to pharmaceutical
    industries.
  4. Understand the responsibilities of QA & QC departments

Course Syllabus

UNIT – I 
Quality Assurance and Quality Management concepts: Definition and concept of Quality control, Quality assurance and GMP
Total Quality Management (TQM): Definition, elements, philosophies
ICH Guidelines: purpose, participants, process of harmonization, Brief overview of QSEM, with special emphasis on Q-series guidelines, ICH stability testing guidelines
Quality by design (QbD): Definition, overview, elements of QbD program, tools
ISO 9000 & ISO14000: Overview, Benefits, Elements, steps for registration
NABL accreditation : Principles and procedures

UNIT - II 
Organization and personnel: Personnel responsibilities, training, hygiene and personal records.
Premises: Design, construction and plant layout, maintenance, sanitation, environmental control, utilities and maintenance of sterile areas, control of contamination.
Equipments and raw materials: Equipment selection, purchase specifications, maintenance, purchase specifications and maintenance of stores for raw materials.

UNIT – III
Quality Control: Quality control test for containers, rubber closures and secondary packing materials.
Good Laboratory Practices: General Provisions, Organization and Personnel, Facilities, Equipment, Testing Facilities Operation, Test and Control Articles, Protocol for Conduct of a Nonclinical Laboratory Study, Records and Reports, Disqualification of Testing Facilities
UNIT – IV
Complaints: Complaints and evaluation of complaints, Handling of return good, recalling and waste disposal.
Document maintenance in pharmaceutical industry: Batch Formula Record, Master Formula Record, SOP, Quality audit, Quality Review and Quality documentation, Reports and documents, distribution records.
UNIT – V
Calibration and Validation: Introduction, definition and general principles of calibration, qualification and validation, importance and scope of validation, types of validation, validation master plan. Calibration of pH meter, Qualification of UV-Visible spectrophotometer, General principles of Analytical method Validation.
Warehousing: Good warehousing practice, materials management

References:
1. Quality Assurance Guide by organization of Pharmaceutical Products of India.

2. Good Laboratory Practice Regulations, 2nd Edition, Sandy Weinberg Vol. 69.
3. Quality Assurance of Pharmaceuticals- A compendium of Guide lines and Related materials Vol I WHO Publications.
4. A guide to Total Quality Management- Kushik Maitra and Sedhan K Ghosh
5. How to Practice GMP’s – P P Sharma. 6. ISO 9000 and Total Quality Management – Sadhank G Ghosh
7. The International Pharmacopoeia – Vol I, II, III, IV- General Methods of Analysis and Quality specification for Pharmaceutical Substances, Excipients and Dosage forms
8. Good laboratory Practices – Marcel Deckker Series
9. ICH guidelines, ISO 9000 and 14000 guidelines

Session Plan

Session 1

Definition and concept of Quality control

PPT-SESSION1 QC

Session 2

Quality assurance and GMP

PPT-SESSION 2 Quality assurance and GMP

Session 3

Total Quality Management (TQM): Definition, elements, philosophies

PPT-SESSION 3 TQM

Session 4

ICH Guidelines: purpose, participants, process of harmonization

PPT-SESSION 4 ICH

Session 5

Brief overview of QSEM, with special emphasis on Q-series guidelines

PDF-SESSION 5 ICH-Q

Session 6

ICH stability testing guidelines

PPT SESSION 4 ICH S

Session 7

Quality by design (QbD): Definition, overview, elements of QbD program, tools

PDF- SESSION 7 QbD

Session 8

ISO 9000 & ISO14000: Overview, Benefits, Elements, steps for registration

ISO_14001_2015_EMS

Session 9

NABL accreditation : Principles and procedures

2015-190225112207 (1)

Session 10

Organization and personnel: Personnel responsibilities, training

personnelgmp-150114163421-conversion-gate01-pages-deleted

Session 11

Organization and personnel: Hygiene and personal records.

personnelgmp-150114163421-conversion-gate01-pages-deleted

Session 12

Premises: Design, construction and plant layout,

premises

Session 13

Premises: maintenance, sanitation, environmental control

premises

Session 14

Utilities and maintenance of sterile areas, control of contamination.

premises

Session 15

Equipments and raw materials: Equipment selection, purchase specifications,

equipments-raw-materials

Session 16

Equipments and raw materials: maintenance, purchase specifications

equipments-raw-materials

Session 17

Maintenance of stores for raw materials

equipments-raw-materials

Session 18

Quality Control: Quality control test for containers,

qctestforcontainers-190227070851-pages-deleted

Session 19

Quality control test for rubber closures and secondary packing materials.

qctestforcontainers-190227070851-pages-deleted

Session 20

Good Laboratory Practices: General Provisions, Organization and Personnel,

GLP

Session 21

Good Laboratory Practices: Facilities,Equipment,

GLP

Session 22

Good Laboratory Practices: Testing Facilities Operation, Test and Control Articles,

Session 23

Protocol for Conduct of a Nonclinical Laboratory Study

Session 24

Good Laboratory Practices: Disqualification of Testing Facilities

GLP

Session 25

Complaints: Complaints and evaluation of complaints,

 

http://www.youtube.com/watch?v=TrbSfsX0tpw

Session 26

Complaints: Handling of return good,

Session 27

Recalling and waste disposal.

Session 28

Document maintenance in pharmaceutical industry: Batch Formula Record, Master Formula Record,

Session 29

Document maintenance in pharmaceutical industry: SOP, Quality audit,

Session 30

Document maintenance in pharmaceutical industry: Quality Review and Quality documentation,

Session 31

Document maintenance in pharmaceutical industry: Reports and documents, distribution records.

Session 32

Calibration and Validation: Introduction, definition and general principles of calibration

Session 33

Calibration and Validation: qualification and validation,

Session 34

Importance and scope of validation

Session 35

Types of validation, validation master plan.

Session 36

Calibration of pH meter

Session 37

Qualification of UV-Visible spectrophotometer

Session 38

General principles of Analytical method Validation

Session 39

Warehousing: Good warehousing practice

Session 40

Warehousing: materials management

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