PHARMACEUTICAL QUALITY CONTROL AND QUALITY ASSURANCE For MPharm (Semester 1) (MQA 103T) As Per PCI Regulations | Nirali Prakashan

1. INTRODUCTION: CONCEPT & EVOLUTION OF QC, QA, GLP, GMP, OVERVIEW OF ICH GUIDELINES-QSEM, WITH SPECIAL EMPHASIS ON Q-SERIES GUIDELINES
2. GOOD LABORATORY PRACTICES
3. THE C-GMP, ITS GUIDELINES AND INTRODUCTION TO FDA (SCHEDULE M), US-FDA (INCLUSIVE OF CDER AND CBER) PHARMACEUTICAL INSPECTION CONVENTION (PIC/S), WHO & EMEA
4. THE c-GMP GUIDELINES ACCORDING TO SCHEDULE M, USFDA (INCLUSIVE OF CDER & CBER), PHARMACEUTICAL INSPECTION CONVENTION (PIC/S), WHO & EMEA (EMA)
5. ANALYSIS OF MATERIALS
6. DOCUMENTATION IN PHARMACEUTICAL INDUSTRY
7. DOCUMENTATION IN PHARMACEUTICAL INDUSTRY-II
8. MANUFACTURING OPERATIONS AND CONTROLS

Dr. Kishor. S. Jain, Dr. Pravin J. Patil, Dr. (Mrs.) Jyoti N. Kadam