BP606T PHARMACEUTICAL QUALITY ASSURANCE (Theory)
Scope: 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.
Objectives: Upon
completion of the course student shall be able to:
Understand the cGMP aspects in a pharmaceutical industry
appreciate the importance of documentation
Understand the scope of quality certifications applicable to
pharmaceutical industries
Understand the responsibilities of QA & QC departments
Course
content:
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
Recommended
Books: (Latest Edition)
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
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