GMP Question & Answer Guide


GMP Question & Answer Guide
The requirements defined in the GMP Guidelines often leave room for interpretation. However, regulators worldwide (EMA, FDA, TGA etc) sometimes publish frequently asked questions on GMP. In a new ECA document these Q&As are summarized in a single source. The Q&As are structured in 4 main GMP Areas (General GMPs, GMP for APIs, GMP for Medicinal Products, GMP for IMPs). The document contains 150 pages of Q&As and is available at no cost on the ECA Webpage. A first set of ECA Q&As have also been included and additional GMP Q&As are planned for the future. Here you can access the GMP Questions and Answers Guide

GMP Question and Answer Guide „GMP Advisor“
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. You can access and download the GMP Q&A Guide here

Please see the table of contents below:

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)

4. GMP for IMPs
4.1. EU GMP (EMA)
4.3 TGA Australia



DR ANTHONY MELVIN CRASTO, Born in Mumbai in 1964 and graduated from Mumbai University, Completed his Ph.D from ICT, 1991,Matunga, Mumbai, India, in Organic Chemistry, The thesis topic was Synthesis of Novel Pyrethroid Analogues, Currently he is working with GLENMARK PHARMACEUTICALS LTD, Research Centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India. Total Industry exp 30 plus yrs, Prior to joining Glenmark, he has worked with major multinationals like Hoechst Marion Roussel, now Sanofi, Searle India Ltd, now RPG lifesciences, etc. He has worked with notable scientists like Dr K Nagarajan, Dr Ralph Stapel, Prof S Seshadri, Dr T.V. Radhakrishnan and Dr B. K. Kulkarni, etc, He did custom synthesis for major multinationals in his career like BASF, Novartis, Sanofi, etc., He has worked in Discovery, Natural products, Bulk drugs, Generics, Intermediates, Fine chemicals, Neutraceuticals, GMP, Scaleups, etc, he is now helping millions, has 9 million plus hits on Google on all Organic chemistry websites. His friends call him Open superstar worlddrugtracker. His New Drug Approvals, Green Chemistry International, All about drugs, Eurekamoments, Organic spectroscopy international, etc in organic chemistry are some most read blogs He has hands on experience in initiation and developing novel routes for drug molecules and implementation them on commercial scale over a 30 year tenure till date Dec 2017, Around 35 plus products in his career. He has good knowledge of IPM, GMP, Regulatory aspects, he has several International patents published worldwide . He has good proficiency in Technology transfer, Spectroscopy, Stereochemistry, Synthesis, Polymorphism etc., He suffered a paralytic stroke/ Acute Transverse mylitis in Dec 2007 and is 90 %Paralysed, He is bound to a wheelchair, this seems to have injected feul in him to help chemists all around the world, he is more active than before and is pushing boundaries, He has 9 million plus hits on Google, 2.5 lakh plus connections on all networking sites, 50 Lakh plus views on dozen plus blogs, He makes himself available to all, contact him on +91 9323115463, email, Twitter, @amcrasto , He lives and will die for his family, 90% paralysis cannot kill his soul., Notably he has 19 lakh plus views on New Drug Approvals Blog in 216 countries...... , He appreciates the help he gets from one and all, Friends, Family, Glenmark, Readers, Wellwishers, Doctors, Drug authorities, His Contacts, Physiotherapist, etc

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