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GMP Training

Good Manufacturing Practices – API & Intermediates (ICH Focused)

Curriculum

22 Sections
41 Lessons
30 Hours

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ICH Q7 – The Story of Global API GMP Harmonization
1
- 1.1
  History
Program Introduction
1
- 2.1
  Introduction to the Active Pharmaceutical Ingredient (API) GMP Training Program
Detailed Glossary
1
- 3.1
  Key GMP and Pharmaceutical Terminology – Foundation for Quality
Module 1: Introduction to ICH Q7
3
- 4.1
  ICH Q7 API GMP – Introduction, Scope & Key Concepts
- 4.2
  Case Study – API Starting Material Determination
- 4.3
  Questionnaire
  20 Minutes5 Questions
Module 2: Quality Management
3
- 5.1
  Quality Management System for API Manufacturing (ICH Q7)
- 5.2
  Practical Exercise – Quality Unit Decision-Making
- 5.3
  Questionnaire – Module 2
  5 Questions
Module 3: Personnel Requirements
3
- 6.1
  Personnel requirements for API Manufacturing (ICH Q7)
- 6.2
  Practical Exercise – Training Program Development
- 6.3
  Module 3: Questionnaire
  5 Questions
Module 4: Buildings and Facilities
3
- 7.1
  Buildings and Facilities requirements for API Manufacturing (ICH Q7)
- 7.2
  Practical Exercise – Facility Layout Evaluation
- 7.3
  Module 4: Questionnaire
  5 Questions
Module 5: Process Equipment
3
- 8.1
  Process Equipment & Systems requirements for API Manufacturing (ICH Q7)
- 8.2
  Practical Exercise — Equipment Qualification Plan
- 8.3
  Module5: Questionnaire
  5 Questions
Module 6: Documentation and Records
3
- 9.1
  Documentation and Records requirements for API Manufacturing (ICH Q7)
- 9.2
  Practical Exercise — Batch Record Review
- 9.3
  Module 6: Questionnaire
  5 Questions
Module 7: Materials Management
3
- 10.1
  Materials Management requirements for API Manufacturing (ICH Q7)
- 10.2
  Practical Exercise — Material Receipt Procedure
- 10.3
  Module 7: Questionnaire
  5 Questions
Module 8: Production and In-Process Controls
3
- 11.1
  Production and In-Process Controls requirements for API Manufacturing (ICH Q7)
- 11.2
  Practical Exercise — IPC (In-Process Control) Strategy Development
- 11.3
  Module 8: Questionnaire
  5 Questions
Module 9: Packaging and Identification
3
- 12.1
  Packaging and Identification Labeling of APIs and Intermediates requirements for API Manufacturing (ICH Q7)
- 12.2
  Practical Exercise: Label Control System Design
- 12.3
  Module 9: Questionnaire
  5 Questions
Module 10: Storage and Distribution
3
- 13.1
  Storage and Distribution Requirements for API Manufacturing (ICH Q7)
- 13.2
  Practical Exercise: Distribution Control System
- 13.3
  Questionnaire
  5 Questions
Module 11: Laboratory Controls
3
- 14.1
  Laboratory Controls
- 14.2
  Detailed Explanation: Practical Exercise – Stability Study Protocol
- 14.3
  Questionnaire
  5 Questions
Module 12: Validation
3
- 15.1
  Validation
- 15.2
  Detailed Explanation: Practical Exercise – Cleaning Validation Protocol
- 15.3
  Questionnaire
  5 Questions
Module 13: Change Control
3
- 16.1
  Change Control
- 16.2
  Practical Exercise: Manufacturing Process Change
- 16.3
  Questionnaire
  5 Questions
Module 14: Rejection and Re-use
3
- 17.1
  Rejection and Re-use
- 17.2
  Practical Exercise: Material Disposition Decision
- 17.3
  Questionnaire
  5 Questions
Module 15: Complaints and Recalls
3
- 18.1
  Complaints and Recalls
- 18.2
  Practical Exercise: Complaint Investigation
- 18.3
  Questionnaire
  5 Questions
Module 16: Contract Manufacturers
3
- 19.1
  Contract Manufacturers
- 19.2
  Practical Exercise: Contractor Qualification Program
- 19.3
  Questionnaire
  5 Questions
Module 17: Agents, Brokers, and Distributors
3
- 20.1
  Agents, Brokers, and Distributors
- 20.2
  Practical Exercise: API Broker Quality System Design
- 20.3
  Questionnaire
  5 Questions
Module 18: APIs by Cell Culture/Fermentation
3
- 21.1
  APIs by Cell Culture/Fermentation
- 21.2
  Practical Exercise: Fermentation Process Control Strategy
- 21.3
  Questionnaire
  5 Questions
Module 19: APIs for Clinical Trials
3
- 22.1
  APIs for Clinical Trials
- 22.2
  Practical Exercise: Clinical Trial API Strategy – Phase I GMP Implementation
- 22.3
  Questionnaire
  5 Questions

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Questionnaire

Detailed Explanation: Practical Exercise – Cleaning Validation Protocol

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