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

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.

You can access and download the GMP Q&A Guide here (1.7 MB)

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

Lab Data Integrity - Part 2: Self Inspections and Audits to Confirm Effective Data Integrity Controls

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Berlin, Germany

15/16 September 2021