GMP Question and Answer Guide „GMP Advisor“ – New Version 2.0. – March 2020

GMP Advisor Q&A

Searching for concrete answers to GMP questions is a time-consuming activity. The document is intended to provide a single source of information. We have summarized GMP questions and answers from regulators around the world. Version 2.0. was released in March 2020

In addition to EMA, FDA, Health Canada, MHRA (UK), TGA (Australia) and ICH, we have also used Q&As from ECA. The subject index of the document contains some of the “GMP Key Words” and enables the finding of Q&As addressing the relevant topic. It is intended to update this comprehensive collection and to also add new Q&As once they are available.

The document is structured according to the organisations which have issued the Q&As: EMA/Europe, MHRA, ECA Foundation, FDA (USA), Health Canada and ICH. To support readers of the document, a “GMP Subject List” with key words provides information where to find certain Q&As. By using this “GMP Subject List” one can find Q&As on certain GMP subjects like “cross contamination”, “equipment”, “audit trail” and many more.

1. EMA Europe

1.1. General GMP Requirements
1.2. EU GMP guide part II: Basic requirements for active substances used as starting materials: GMP compliance for active substances
1.3. EU GMP guide part II: Basic requirements for active substances used as starting materials: GMP compliance for active substances in investigational medicinal products (IMPs)
1.4. EU GMP guide annexes: Supplementary requirements:
Annex 1: Manufacture of sterile medicinal products 
1.5. EU GMP guide annexes: Supplementary requirements:
Annex 6: Manufacture of medicinal gases
1.6. EU GMP guide annexes: Supplementary requirements:
Annex 8: Sampling of starting and packaging materials: Glycerol
1.7. EU GMP guide annexes: Supplementary requirements:
Annex 11: Computerised systems
1.8. EU GMP guide annexes: Supplementary requirements:
Annex 13
1.9. EU GMP guide annexes: Supplementary requirements:
Annex 16 (Updated May 2018)
1.10. General GMP
1.11. GMP certificates, non-compliance statements and manufacturing authorisations
1.12. Inspection coordination
1.13. Data integrity (New August 2016)
1.14. GDP requirements (New June 2018)
1.15. Active substance registration (New July 2018) 
1.16. EU GMP guide part IV: GMP requirements for advanced therapy medicinal products (ATMP): Guidelines on GMP specific to ATMPs (New June 2019)

2. MHRA (Europe/UK)

2.1. Quality Risk Management
2.2. Out of Specification

3. ECA Foundation

3.1 EU GMP Annex 11: Computerised System
3.2. Data Integrity
3.3. Visual Inspections
3.4. Qualified Person
3.5. Good Distribution Practices (GDP)

4. FDA (USA)

4.1. General Provisions
4.2. Building and Facilities
4.3. Equipment
4.4. Control of Components and Drug Product Containers and Closures
4.5. Production and Process Controls
4.6. Production and Process Controls
4.7. Laboratory Controls 
4.8. Records and Reports
4.9. Returned and Salvaged Drug Products

5. Health Canada 

5.1. General Issues
 Equipment - C.02.005
 Personnel - C.02.006
 Sanitation - C.02.007 & C.02.008
 Raw Material Testing - C.02.009 & C.02.010
 Manufacturing Control - C.02.011 & C.02.012
 Quality Control Department - C.02.013, C.02.014 & C.02.015
 Packaging Material Testing - C.02.016 & C.02.017
 Finished Product Testing - C.02.018 & C.02.019
 Records - C.02.020, C.02.021, C.02.022, C.02.023 & C.02.024
 Samples - C.02.025 & C.02.026
 Stability - C.02.027 & C.02.028
5.2. Sterile Products 

6. ICH

6.1. ICH: Q8, Q9 and Q10 
6.2. FDA and EMA on Design Space Verification

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