BP606T Quality Assurance Theory
UNIT I
1.1 Quality Assurance and Quality Management concepts: Definition and concept of Quality control, Quality assurance, and GMP
1.2 Total Quality Management (TQM): Definition, elements, philosophies
1.3 ICH Guidelines: purpose, participants, the process of harmonization, Brief overview of QSEM, with special emphasis on Q-series guidelines, ICH stability testing guidelines
1.4 QbD: Definition, overview, elements of QbD program, tools ISO 9000 & ISO14000: Overview, Benefits, Elements, steps for registration
1.5 NABL accreditation: Principles and procedure
UNIT II
2.1 Organization and personnel:
Personnel responsibilities, training, hygiene, and personal records.
Premises: Design, construction, and plant layout, maintenance, sanitation, environmental controls, utilities and maintenance of sterile areas, control of contamination.
2.2 Equipment and raw materials: Equipment selection, purchase specifications, maintenance, purchase specifications, and maintenance of stores for raw materials
UNIT III
3.1 Quality Control:
Quality control test for containers, rubber closures, and secondary packing materials
3.2 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
4.1 Complaints: Complaints and evaluation of complaints, Handling of return goods, recalling, and waste disposal.
4.2 Document maintenance in the pharmaceutical industry:
Batch Formula Record,
Master Formula Record,
SOP,
Quality audit,
Quality Review and Quality documentation,
Reports and documents,
Distribution records.
UNIT V
5.1 Calibration and Validation:
Introduction, definition and general principles of calibration, qualification and validation,
importance and scope of validation,
Types of validation,
Validation master plan (VMP)
Calibration of pH meter,
Qualification of UV-Visible spectrophotometer, General principles of Analytical method Validation.
5.2 Warehousing: Good warehousing practice, materials management
Reference Books (Latest Editions to be adopted)
- Quality Assurance Guide by organization of Pharmaceutical Products of India.
- Good Laboratory Practice Regulations, 2nd Edition, Sandy Weinberg Vol. 69.
- Quality Assurance of Pharmaceuticals- A compendium of Guide lines and Related materials Vol I WHO Publications.
- A guide to Total Quality Management- Kushik Maitra and Sedhan K Ghosh
- How to Practice GMP’s – P P Sharma.
- ISO 9000 and Total Quality Management – Sadhank G Ghosh
- The International Pharmacopoeia – Vol I, II, III, IV- General Methods of Analysis and Quality specification for Pharmaceutical Substances, Excipients and Dosage forms
- Good laboratory Practices – Marcel Deckker Series
- ICH guidelines, ISO 9000 and 14000 guidelines
Third Year B Pharm Notes, Syllabus, Books, PDF Subjectwise/Topicwise
Suggested readings:
Recommended readings:
