EU GMP

EU GMP

EU GMP

EU GMP

A brief overview of EU GMP

Published: 24 April 2024

EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use.

These guidelines are available free of charge and we have collated them here for easy download.

EU GMP Annex 1: Manufacture of Sterile Medicinal Products

https://www.gmp-compliance.org/files/guidemgr/20220825_gmp-an1_en_0.pdf

EU GMP Annex 2: Manufacture of Biological Medicinal Products for Human Use

https://www.gmp-compliance.org/files/guidemgr/2018_annex2_en.pdf

EU GMP Annex 3: Manufacture of Radiopharmaceuticals

https://www.gmp-compliance.org/files/guidemgr/2008_09_annex3[1].pdf

EU GMP Annex 4: Manufacture of Veterinary Medicinal Products other than Immunological Veterinary Medicinal Products

https://www.gmp-compliance.org/files/guidemgr/anx04en200408[1].pdf

EU GMP Annex 5: Manufacture of Immunological Veterinary Medicinal Products

https://www.gmp-compliance.org/files/guidemgr/2-8-4-5.pdf

EU GMP Annex 6: Manufacture of Medicinal Gases

https://www.gmp-compliance.org/files/guidemgr/2009_07_annex6.pdf

EU GMP Annex 7: Manufacture of Herbal Medicinal Products

https://www.gmp-compliance.org/files/guidemgr/vol4_an7_2008_09.pdf

EU GMP Annex 8: Sampling of Starting and Packaging Materials

https://www.gmp-compliance.org/files/guidemgr/2-8-4-8.pdf

EU GMP Annex 9: Manufacture of Liquids, Creams and Ointments

https://www.gmp-compliance.org/files/guidemgr/2-8-4-9.pdf

EU GMP Annex 10: Manufacture of Pressurised Metered Dose Aerosol Preparations for Inhalation

https://www.gmp-compliance.org/files/guidemgr/2-8-4-10.pdf

EU GMP Annex 11: Computerised Systems

https://www.gmp-compliance.org/files/guidemgr/annex11_01-2011_en.pdf

EU GMP Annex 12: Use of Ionising Radiation in the Manufacture of Medicinal Products

https://www.gmp-compliance.org/files/guidemgr/2-8-4-12.pdf

EU GMP Annex 13: Investigational Medicinal Products

https://www.gmp-compliance.org/files/guidemgr/2009_06_annex13.pdf

EU GMP Annex 14: Manufacture of Medicinal Products Derived from Human Blood or Plasma

https://www.gmp-compliance.org/files/guidemgr/annex14_rev30-03_2011_en.pdf

EU GMP Annex 15: Qualification and Validation

https://www.gmp-compliance.org/files/guidemgr/2015-10_annex15.pdf

EU GMP Annex 16: Certification by a Qualified Person and Batch Release

https://www.gmp-compliance.org/files/guidemgr/v4_an16_201510_en.pdf

EU GMP Annex 17: Real Time Release Testing and Parametric Release

https://www.gmp-compliance.org/files/guidemgr/2018_annex17_en.pdf

EU GMP Annex 18: NOT IN USE

EU GMP Annex 19: Reference and Retention Samples

https://www.gmp-compliance.org/files/guidemgr/Annex19_Ref_Ret_Smpls.pdf

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Peter Phillips

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ISO Cleanroom were very easy and practical to work with. Both Toni and Amaleed were knowledgeable and very flexible - looking forward to working with them in for future projects.

Siobhan Carey

I recently contracted Iso Cleanroom to design and build two modular ISO Class 6 cleanrooms so that our small orthobiologics company could implement in-house manufacture. They delivered on all of their commitments on cost, schedule and quality with no fuss. They showed up they day they said the would and finished up the day they said they would. They were extremely organised and meticulous, and helped us to address some unforeseen issues that cropped up during the installation.

Gareth Evans

We contracted ISO Cleanroom to design, build and validate a large cleanroom in our new facility. Toni really knows her business, and was very helpful through the design process, enabling us to make the most of the available space. When it came to installation, Anthony and his team did an exceptional job, keeping the install to schedule. We are very happy with the professional service we have had from ISO Cleanroom and would not hesitate in recommending others to use them for any cleanroom requirements.