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Courses
GMP Trainings
Good Manufacturing Practices – API & Intermediates (ICH Focused)
Curriculum
22 Sections
41 Lessons
Lifetime
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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 Minutes
5 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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