JAWAHARLAL NEHRU TECHNOLOGICAL UNIVERSITY HYDERABAD

Course Objectives

Total quality management constitutes very useful chapter like –good

manufacturing practices, GLP, GCP, ICH etc. Which increases the knowledge of students in various quality control & regulatory aspects.

Course Outcomes

Total quality management helps the students to learn the established regulatory

guidelines in GMP, GCP, GLP, USFDA, WHO, ISO etc to become a perfect budding pharmacist. It is very useful to students to acquire vast knowledge regarding the quality control aspects of different regulatory bodies as per their requirements throughout the world.

UNIT - I

Concepts and Philosophy of TQM, GLP, GMP (orange guide).

UNIT - II

Drug regulatory and accrediting agencies of the world (USFDA, TGA, ICH, WHO, ISO etc.)

UNIT - III

Good manufacturing practices: Organization and personnel, responsibilities, training, hygiene. Premises: Location, design, plant layout, construction, maintenance and sanitation, environmental control, utilities and services like gas, water, maintenance of sterile areas, control of contamination. Equipments: Selection, purchase specifications, maintenance, clean-in-place, sterilize-in-place, methods (TP and STP). Raw materials: Purchase specifications, maintenance of stores, selection of vendors, controls on raw materials and finished dosage forms. Manufacture of and controls on dosage forms: Manufacturing documents, master formula, batch formula records, standard operating procedures, quality audits of manufacturing processes and facilities. In process quality controls on various dosage forms; sterile and non–sterile, standard operating procedures for various operations like cleaning, filling, drying, compression, coating, disinfections, sterilization, membrane filtration etc., Packaging and labelling control, line clearance, reconciliation of labels, cartons and other packaging materials. Quality Control Laboratory: Responsibilities, good laboratory practices, routine controls instruments, reagents, sampling plans, standard test procedures, protocols, non-clinical testing, controls on animal house. Data generation and storage, quality control documents, retention samples, records and audits of quality control facilities. Finished products release, quality review, quality audits, batch release document.

UNIT - IV

Regulatory Considerations for Pre-clinical and Clinical Evaluation: Pre-clinical requirements currently in use. Regulatory requirements of single dose and repeat dose toxicity studies. Study of specific toxicities such as mutagenicity, carcinogenicity and teratoginicity. Animal pharmacokinetics and toxicokinetics. Regulatory requirements of clinical evaluation, pharmacokinetics in man genetic polymorphism. Design and interpretation of clinical trials. Quality assurance standards as per ISO.

UNIT - V

Globalization of drug industry, present status and scope of pharmaceutical industry in India. WHO and NABL certification, ICH guidelines for manufacturing and quality assurance of drug formulation.

TEXT AND REFERENCE BOOKS:

• 1. Guidelines for Developing National Drug Policies; WHO Publications, 1998. R19 M.PHARM PHARMACEUTICAL REGULATORY AFFAIRS
• 2. Quality Assurance of Pharmaceuticals–A Compendium of Guidelines and Related Materials, Vol.–1; WHO Publications.
• 3. A Guide to Total Quality Management by Kaushik Maitra and Sedhan K. Ghosh.
• 4. GMP by Mehra.
• 5. How to Practice GMP by P.P. Sharma.
• 6. ISO 9000 and Total Quality Management by Sadhan K. Ghosh.
• 7. Good Manufacturing Practices for Pharmaceuticals-A Plan for Total Quality Control by Sidney H. Willing & James R Stoker. (Drugs & Pharm. Sciences) Vol. 78; Marcel Dekker Inc.
• 8. OPPI-Quality Assurance, USP.
• 9. Current good manufacturing practices for pharmaceuticals by Manohar A. Potdar
• 10. Quality assurance and quality management in pharmaceutical industry by Y. Anjaneyulu and marayya
• 11. Total Quality Management, An integrated Approach by D. R. Kiran, BS Publications
• 12. Total Quality Management, 3rd edition by Joel E. Ross. CRC press R19 M.PHARM PHARMACEUTICAL REGULATORY AFFAIRS M.Pharm I Year I Sem (Pharmaceutical Regulatory Affairs)