Unit I

Quality Assurance and Quality Management concepts: Definition and concept of Quality control, Qual- ity 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

(10 Hours)

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.

(10 Hours)

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

(10 Hours)

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.

(08 Hours)

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

(07 Hours)

‘Pharmaceutical Quality Assurance – Theory’ is a course offered in the sixth semester of B. Pharm program at School of Pharmacy, Health Sciences campus, Amrita Vishwa Vidyapeetham.

Course Duration: 45 Hours

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:

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

Recommended Books (Latest Editions)

1. Quality Assurance Guide by organization of Pharmaceutical Products of India.
2. Good Laboratory Practice Regulations, 2nd Edition, SandyWeinberg Vol. 69.
3. Quality Assurance of Pharmaceuticals- A compendium of Guide lines and Related materials Vol IWHO Publications.
4. A guide to Total QualityManagement- Kushik Maitra and Sedhan K Ghosh
5. How to Practice GMP’s – P P Sharma.
6. ISO 9000 and Total QualityManagement – 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