GMP Question and Answer Guide „GMP Advisor“

GMP Advisor Q&A

Searching for concrete answers to GMP questions is a time-consuming activity. The document we now offer is intended to provide a single source of information. We have summarized GMP questions and answers from regulators around the world.

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 into the 4 main GMP areas: General GMPs (applicable to medicinal products, APIs and IMPs), GMP for Medicinal Products, GMP for APIs and GMP for Investigational Medicinal Products (IMPs). In addition, it is indicated which organization has issued the Question and Answers.

1. General GMPs

1.1 EMA Europe
1.1.1 General
1.1.2 EU GMP Annex 1 Sterile Products
1.1.3 EU GMP Annex 6: Manufacture of medicinal gases
1.1.4 EU GMP Annex 8: Sampling
1.1.5 EU GMP Annex 11: Computerised systems
1.1.6 EU GMP Annex 16 QP and Batch Release
1.1.7 EU GMP Annex 19 Reference Standards
1.1.8 Impurities

1.2 MHRA (Europe/UK)
1.2.1Quality Risk Management
1.2.2 Out of Specification

1.3 ECA Academy (Europe)
1.3.1 EU GMP Annex 11: Computerised System

1.4 FDA (USA)
1.4.1 General GMP

1.5 Health Canada
1.5.1 General Issues
1.5.2 Sterile Products

1.6. TGA Australia
1.6.1 General Issues
1.6.9 Reference and retention samples (Annex 19)

1.7 ICH
1.7.1 ICH: Q8, Q9 and Q10
1.7.2 FDA and EMA on Design Space Verification

2. GMP for Medicinal Products

2.1 EU GMP (EMA)

2.2. TAG Australia
2.2.1 Manufacture of sterile medicinal products (Annex 1)
2.2.2 Manufacture of biological medicinal products (Annex 2)
2.2.3 Manufacture of radiopharmaceuticals (Annex 3)
2.2.4 Manufacture of herbal medicinal products (Annex 7)
2.2.5 Sampling of starting and packaging materials (Annex 8)
2.2.6 Qualification and validation (Annex 15)

3. GMP for APIs

3.1 EU GMP (EMA)
3.2 EU GMP (MHRA/UK)

4. GMP for IMPs

4.1. EU GMP (EMA)
4.2 EU GMP (MHRA/UK)
4.3 TGA Australia

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