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| Course Objectives - Addresses the application of Good Manufacturing Practices (GMP) principles to pharmaceutical industries and laboratories.
- Discusses the general principles of GMPs and their importance.
- Overview of the global regulatory system for human medicines.
- An introduction to pharmacovigilance, variations and renewals given in the context of the lifecycle.
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| Course Contents - GMP requirements for laboratories.
- Laboratory documents and document control.
- Handling and documentation of raw data.
- Controlling growth media.
- Aseptic techniques.
- Monitoring.
- Laboratory equipment and Calibration.
- Training practices.
- The Regulatory Agency Governance.
- Global Regulatory framework and regulations 7 guidance.
- Site master file (SMF).
- Drug master file (DMS).
- Marketing Authorization for Medicinal products.
- Lifecycle Management.
- Change control and management.
- Audits and self-inspections.
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| Duration | |
| Certification - Certificate approved by The AASTMT
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| Teaching Language | |
| Location - Productivity and Quality Institute or Company Headquarters
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| Instructor/Trainer Qualification - Academic Professors with minimum 15 Years’ Experience in Pharmaceutical Industries.
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