UNIQUE SERIES AKTU Syllabus
BP708T AEC1

Current Good Manufacturing Practices (cGMP) (Theory)

L-T-P1-0-0 Session2026-27 TypeTheory
Appears in 1 semester

B.Pharm · Sem 7 (AEC – Elective 6)

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Syllabus

5 units · 15 lecture hours
Unit1

Unit 1

3 hrs

Standard Operating Procedures (SOP), Systems for Training & Development in Pharmaceuticals Introduction to SOPs, SOP on SOP, Contents of a standard SOP, Writing a good SOP, Distribution and control of SOPs. Introduction to Training and development, Training needs identification, Training and evaluation.

Unit2

Unit 2

3 hrs

A comprehensive review of cGMP and various important FDA guidelines List of major guidelines referred in pharmaceuticals Effectively reading and understanding the guidelines

Unit3

Unit 3

3 hrs

Important Quality Assurance and cGMP systems adopted in Pharmaceuticals Introduction to Quality Management Systems (QMS), Manufacturing Assurance, Analytical Assurance, Developments Quality Assurance, Engineering Assurance. Concepts of corrective and preventive actions (CAPA), Deviations and Incidents handling. Handling of non-conforming materials

Unit4

Unit 4

3 hrs

Handling of Customer Complaints Introduction to complaints, Types of complaints Understanding Manufacturing defects and Quality issues Handling and investigation of customer complaints

Unit5

Unit 5

3 hrs

Regulatory Audits Introduction to audits and Types of audits. Preparation for a successful audit, Audit teams and internal audits. Handling of FDA inspections: FDA observations, Compliance and replying to an audit report.

Course Objectives6 points
  • The objectives of this course are to:
  • Explain the structure, purpose, and implementation of Standard Operating Procedures (SOPs) in pharmaceutical operations.
  • Develop understanding of training and development systems, including training needs assessment and evaluation methods used in the pharmaceutical industry.
  • Describe the principles of current Good Manufacturing Practices (cGMP) and key regulatory guidelines relevant to pharmaceutical quality assurance.
  • Examine core pharmaceutical quality systems such as Quality Management Systems (QMS), CAPA, deviation management, and non-conformance handling.
  • Understand procedures for managing customer complaints, investigating quality issues, and ensuring product safety and regulatory compliance.
Course Outcomes (COs)5 outcomes

After completion of the course student will be able to:

  1. CO1Understand the structure of SOPs, its writing and approval system, Importance of training, development, training needs identification and evaluation.
  2. CO2Understand the major FDA guidelines (regulated and semi regulated markets) and its understanding.
  3. CO3Impart knowledge on manufacturing assurance, analytical assurance, engineering assurance etc, and handling systems for non-conformances.
  4. CO4Procedures used to investigate market complaints and its closure.
  5. CO5Impart knowledge on preparing for the regulatory audits, reports handling and the audits.
Recommended References (Preferably latest edition):6 books
  1. Good Manufacturing Practices for Pharmaceuticals Joseph D. Nally, CRC Press
  2. Quality Assurance of Pharmaceuticals: A Compendium of Guidelines and Related Materials (Vol. 1 & 2) World Health Organization (WHO), WHO Press
  3. Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations U.S. FDA, CDER/CDRH Guidance Document
  4. Pharmaceutical Production and Packaging Technologies Michael J. Groves, CRC Press
  5. Pharmaceutical Quality by Design: A Practical Approach Walkiria S. Schlindwein & Mark Gibson, Wiley
  6. Government of India, Ministry of Health and Family Welfare (2023) Drugs and Cosmetics Rules, 1945: Amendment introducing revised Schedule M Good Manufacturing Practices. Gazette of India, Notification G.S.R. 922(E), 28 December. Course Title Course Type

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Official AKTU syllabus

This subject is on page 258, 259, 260 of the original AKTU PDF.

Official AKTU syllabus PDF ↗