Course Objectives

1. To study the various aspects of quality control and assurance aspects of pharmaceutical.
2. Understanding of important parameters such as cGMP, QC tests, documentation, Quality certifications, GLP and regulatory.

Learning Outcomes

1. The cGMP aspects in a pharmaceutical industry
2. Importance of documentation
3. Scope of quality certifications applicable to Pharmaceutical industries
4. Responsibilities of QA & QC

Course Syllabus

Module-I

Introduction to Quality Control & Quality Assurance ,Introduction, Scope, Need and General Requirements for Standardization of Forensic Science Laboratory.
Module-II
Testing and Calibration Procedures, Total Quality Assurance, Quality Control, Quality Planning.
Module-III

Laboratory Management Procedure ,Lab Information Management System, Validation of Equipment and Safety Protocols.
Module-IV

Quality Audit Definition, Types of Audit - Internal Audit and External Audit, Need of Audit, Importance of Audit and Forensic Significance.
Module-V

Accreditation & Certificate NABL - Introduction & Relevant Provisions
Module-VI

Accreditation & Certificate, ISO - Introduction & Relevant Provisions
Module-VII

Accreditation & Certificate-IEC & BIS - Introduction & Relevant Provisions

Session Plan

Session 1

Introduction, Scope, Need and General Requirements for Standardization of Forensic Science Laboratory.

PDF- CURRENT QC QA GUIDELINES

Session 2

Testing and Calibration Procedures

PDF-testing and calibration by FSL

Session 3

Total Quality Assurance, Quality Control, Quality Planning

PDF-Quality Management in FSL

Session 3

Total Quality Assurance, Quality Control, Quality Planning

PDF-Quality Management in FSL

Session 4

Total Quality Assurance, Quality Control, Quality Planning

PDF-Total Quality Assurance, Quality Control, Quality Planning

Session 5

Lab Information Management System, Validation of Equipment and Safety Protocols

PDF-Satandardrization of FSL (Introduction) (1)

Session 6

Definition, Types of Audit - Internal Audit and External Audit

PDF-Definition, Types of Audit - Internal Audit and External Audit

Session 7

Need of Audit, Importance of Audit and Forensic Significance.

PDF-Forensic_Audit

Session 8

NABL - Introduction & Relevant Provisions

PDF-NABL

Session 9

ISO - Introduction & Relevant Provisions

PDF-Requirment as ISO 17025 for Laboratory

Session 10

IEC & BIS - Introduction & Relevant Provisions

PDF-IEC

PDF-BIS

Text and Reference Books

1. Quality Assurance Guide by organization of Pharmaceutical Procedures of India, 3rd revised edition, Volume I & II, Mumbai
2. Good Laboratory Practice Regulations, 2nd Edition, Sandy Weinberg 69, Marcel Dekker Series, 1995.
3. Quality Assurance of Pharmaceuticals- A compedium of Guide lines and Related materials Vol I & II, 2nd edition, WHO Publications,
4. How to Practice GMP’s – P P Sharma, Vandana Publications, Agra