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EU (GMP) Guidelines

EudraLex – Volume 4 Good manufacturing practice (GMP) Guidelines

Part I – Basic Requirements for Medicinal Products

Chapter 1 Pharmaceutical Quality System (31 January 2013)

Chapter 2 Personnel (16 February 2014).

Chapter 3 Premise and Equipment (1 March 2015)

Chapter 4 Documentation (January 2011) 

Chapter 5 Production (1 March 2015)

Chapter 6 Quality Control (1 October 2014)

Chapter 7 on Outsourced activities (31 January 2013)

Chapter 8 Complaints and Product Recall (1 March 2015)

Chapter 9 Self Inspection

Part II – Basic Requirements for Active Substances used as Starting Materials

Basic requirements for active substances used as starting materials (NEW August 2014)

Part III – GMP related documents 

 Site Master File 

Q9 Quality Risk Management

Q10 Note for Guidance on Pharmaceutical Quality System

MRA Batch Certificate

Template for the ‘written confirmation’ for active substances exported to the European Union for medicinal products for human use (Version 2, January 2013)

Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities.

Annexes

Annex 1          Manufacture of Sterile Medicinal Product

http://ec.europa.eu/health/files/eudralex/vol-4/2008_11_25_gmp-an1_en.pdf

Annex 2          Manufacture of Biological active substances and Medicinal Products for Human Use

http://ec.europa.eu/health/files/eudralex/vol-4/vol4-an2__2012-06_en.pdf

Annex 3          Manufacture of Radiopharmaceuticals

http://ec.europa.eu/health/files/eudralex/vol-4/2008_09_annex3_en.pdf

Annex 4          Manufacture of Veterinary Medicinal Products other than Immunological Veterinary Medicinal Products

http://ec.europa.eu/health/files/eudralex/vol-4/pdfs-en/anx04en200408_en.pdf

Annex 5          Manufacture of Immunological Veterinary Medicinal Products

http://ec.europa.eu/health/files/eudralex/vol-4/pdfs-en/anx05en200408_en.pdf

Annex 6          Manufacture of Medicinal Gases

http://ec.europa.eu/health/files/eudralex/vol-4/2009_07_annex6.pdf

Annex 7          Manufacture of Herbal Medicinal Products

http://ec.europa.eu/health/files/eudralex/vol-4/vol4_an7_2008_09_en.pdf

Annex 8          Sampling of Starting and Packaging Materials

http://ec.europa.eu/health/files/eudralex/vol-4/pdfs-en/anx08_en.pdf

Annex 9          Manufacture of Liquids, Creams and Ointments

http://ec.europa.eu/health/files/eudralex/vol-4/pdfs-en/anx09_en.pdf

Annex 10        Manufacture of Pressurised Metered Dose Aerosol Preparations for Inhalation

http://ec.europa.eu/health/files/eudralex/vol-4/pdfs-en/anx10_en.pdf

Annex 11        Computerized Systems (revision January 2011)

http://ec.europa.eu/health/files/eudralex/vol-4/annex11_01-2011_en.pdf

Annex 12        Use of Ionising Radiation in the Manufacture of Medicinal Product

http://ec.europa.eu/health/files/eudralex/vol-4/pdfs-en/anx12_en.pdf

Annex 13        Manufacture of Investigational Medicinal Products

http://ec.europa.eu/health/files/eudralex/vol-4/2009_06_annex13.pdf

Annex 14        Manufacture of Products derived from Human Blood or Human Plasma

http://ec.europa.eu/health/files/eudralex/vol-4/annex14_rev30-03_2011_en.pdf

Annex 15        Qualification and validation

http://ec.europa.eu/health/files/eudralex/vol-4/2015-10_annex15.pdf

Annex 16        Certification by a qualified person and Batch Release Current

Deadline for coming into operation: 15 April 2016

http://ec.europa.eu/health/files/eudralex/vol-4/v4_an16_201510_en.pdf

 

Annex 17        Parametric Release

http://ec.europa.eu/health/files/eudralex/vol-4/pdfs-en/v4an17_en.pdf

Draft revised Annex 17

http://ec.europa.eu/health/human-use/quality/pc_quality/consultation_document_annex_17.pdf

Annex 19        Reference and Retention Samples

http://ec.europa.eu/health/files/eudralex/vol-4/pdfs-en/2005_12_14_annex19_en.pdf

Glossary

http://ec.europa.eu/health/files/eudralex/vol-4/pdfs-en/glos4en200408_en.pdf

Other documents related to GMP

Compilation of Community Procedures on Inspections and Exchange of Information updated to include new EU formats and procedures

http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC500004706.pdf

“A revised version of the “Guidelines on Good Distribution Practice of Medicinal Products for Human Use“ was published in the Official Journal and is applicable as of 24 November 2013 (OJ C 343/1, 23.11.2013).

http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:C:2013:343:0001:0014:EN:PDF

 

 

 

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About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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