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/Current Good Manufacturing Practices (cGMP)
Semester VII · PCI syllabus 2026
Current Good Manufacturing Practices (cGMP)
BP708T-E1
1 credit
Elective
Coming soon
Unit 1: Unit 1
- 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
Unit 2: Unit 2
- Introduction to Training and development, Training needs identification, Training and evaluation. A comprehensive review of cGMP and various important FDA guidelines
- List of major guidelines referred in pharmaceuticals
Unit 3: Unit 3
- Effectively reading and understanding the guidelines Important Quality Assurance and cGMP systems adopted in Pharmaceuticals
- Introduction to Quality Management Systems (QMS), Manufacturing Assurance, Analytical Assurance, Developments
Unit 4: Unit 4
- Quality Assurance, Engineering Assurance
- Concepts of corrective and preventive actions (CAPA), Deviations and Incidents handling. Handling of non-conforming materials Handling of Customer Complaints
- Introduction to complaints, Types of complaints
- Understanding Manufacturing defects and Quality issues
Unit 5: Unit 5
- Handling and investigation of customer complaints Regulatory Audits
- Introduction to audits and Types of audits
- Preparation for a successful audit, Audit teams and internal audits
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Is elective ka content abhi production mein hai — syllabus official PCI curriculum se hai.