Pharmaceutical Quality Assurance

Shree Sai Prakashan is writing a full set of B.Pharm titles to this new NEP 2020 syllabus. Get notified the moment the book for this subject is released, or pre-book sets for your college.

Unit 1 · Quality Assurance and Quality Management Systems 10 hrs

The concepts of quality assurance, quality control and total quality management; quality-management systems and QSEM, with particular emphasis on the ICH Q-series guidelines; and the principles underlying good manufacturing practice.

Unit 2 · Organization, Personnel, Premises and Materials 10 hrs

Organization and personnel responsibilities; premises and plant layout; materials management including User Requirement Specifications (URS); and the handling and maintenance of equipment and facilities under GMP.

Unit 3 · Quality Control and Good Laboratory Practices 10 hrs

In-process and finished-product quality-control tests for tablets, capsules, liquids and semisolids; and Good Laboratory Practice — general provisions, organization and personnel, facilities, equipment and standard operating procedures.

Unit 4 · Documentation, Complaints and Product Recall 8 hrs

GMP documentation — the Batch Formula Record, Master Formula Record and Drug Master File, and the specifications for primary and secondary packing materials; and the handling and evaluation of complaints, returned goods, recalls and waste disposal.

Unit 5 · Calibration and Validation 7 hrs

The introduction, definitions, importance and general principles of calibration and validation; calibration of weights, measures and pH meters; qualification of the UV-visible spectrophotometer, electronic balance, IR spectrophotometer and HPLC; and the general principles of analytical method validation as per ICH Q2.