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
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)
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
“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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