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Home / Syllabus / B.Sc. (Biotechnology) / TY BSc Biotechnology / Semester 5 / Good Practices and Quality Assurance in Industry

B.Sc. (Biotechnology) Good Practices and Quality Assurance in Industry Syllabus - Mumbai University 2026

This is the TY BSc Biotechnology syllabus under NEP 2020, in force from the academic year 2026-27. The University still examines the earlier Choice Based papers alongside it — her third-year office registers name that scheme — so check which scheme your exam form names before you revise.

Good Practices and Quality Assurance in Industry Syllabus.pdf
Major · Semester 5 · TY BSc Biotechnology · 2 credits · 50 marks

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Syllabus for Good Practices and Quality Assurance in Industry

Major · Semester 5 · TY BSc Biotechnology · 2 credits · 50 marks

Module I: GMP, GLP, QA & QC, GCP

  • Concept of GMP, Guidelines to GLP (2 lectures)
  • Requirements of GMP implementation. (2 Lectures)
  • Documentation of GMP Practices. (2 Lectures)
  • Quality Control (QC): Concept of QC. (2 Lectures)
  • Requirements of implementing QC. (2 Lectures)
  • Concept of GLP and GLP Requirements: Resources, (2 Lectures)
  • QA Concepts - (1 Lecture)
  • GCP - Introduction to Good Clinical Practice (GCP), The Good Clinical Practice Guidelines.(2 lectures)

Module II: Document Maintenance in Pharmaceutical Industry

  • Preparation of SOP (2 lectures)
  • Audits: Internal, external regulatory (1 lecture)
  • Sources and control of contamination, extent of microbial contamination, factors determining the outcome of a medicament borne infection.(5 Lectures)
  • Microbial Limit Test (2 Lectures)
  • Quality control and quality assurance of sterile products:
  • Bioburden,Test for sterility, Parametric release, Pyrogen. (3 Lectures)
  • Validation and in-process monitoring of sterilisation procedure: Physical,chemical and biological indicators (2 Lectures)

Textbooks

  • 1 WHO Handbook of Good Laboratory Practices (GLP), Second edition TDRO
  • 2 Hugo and Russells, Pharmaceutical Microbiology 8th Edition
  • 3 Pharmaceutical Microbiology Dr. Nitin Kumar, Mr. Umesh Deshta, Ms. Pinka, Mr. Rajat, Mr. Aakarshan Thakur.
  • 4 A Practical Guide to Clinical Trials — Duolao Wang & Ameet Bakhai.
  • 1 Modern Pharmacology with clinical Applications Craig,C.R, Stitzel,R.E 5th edition.
  • 2 Clinical Pharmacology Bennet, PN, Brown,M.J, Sharma, P 11th edition Elsevier.

Reproduced from the University of Mumbai syllabus for B.Sc. (Biotechnology) under NEP 2020, in force from the academic year 2026-27. Wording is as printed in that syllabus. Module numbering is as printed there too.

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