EudraLex - Volume 4 Good manufacturing practice (GMP) Guidelines.

Volume 4 of "The rules governing medicinal products in the European Union" contains guidance for the interpretation of the principles and guidelines of good manufacturing practices for medicinal products for human and veterinary use laid down in Commission Directives 91/356/EEC, as amended by Directive 2003/94/EC, and 91/412/EEC respectively.


  • Introductionpdf(33 KB) (7/02/2011)
  • Commission Directive 2003/94/EC, of 8 October 2003, laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use
    Replacement of Commission Directive 91/356/EC of 13 June 1991 to cover good manufacturing practice of investigational medicinal products.
  • Commission Directive 91/412/EEC of 23 July 1991 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products.

Part I - Basic Requirements for Medicinal Products

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

 Part III - GMP related documents 


Table Eudralex

Annex 1

Manufacture of Sterile Medicinal Products pdf(122 KB)

Annex 2

Manufacture of Biological active substances and Medicinal Products for Human Usepdf(171 KB) ((into operation since 31 January 2013)

Annex 3

Manufacture of Radiopharmaceuticalspdf(68 KB)

Annex 4

Manufacture of Veterinary Medicinal Products other than Immunological Veterinary Medicinal Productspdf(14 KB)

Annex 5

Manufacture of Immunological Veterinary Medicinal Productspdf(43 KB)

Annex 6

Manufacture of Medicinal Gases pdf(48 KB)

Annex 7

Manufacture of Herbal Medicinal Productspdf(23 KB)

Annex 8

Sampling of Starting and Packaging Materialspdf(20 KB)

Annex 9

Manufacture of Liquids, Creams and Ointmentspdf(13 KB)

Annex 10

Manufacture of Pressurised Metered Dose Aerosol Preparations for Inhalationpdf(17 KB)

Annex 11

Computerised Systems (revision January 2011) pdf(22 KB)

Annex 12

Use of Ionising Radiation in the Manufacture of Medicinal Productspdf(50 KB)

Annex 13

Manufacture of Investigational Medicinal Productspdf(67 KB)

Annex 14

Manufacture of Products derived from Human Blood or Human Plasmapdf(50 KB) - May 2011

Annex 15

Qualification and validationpdf(95 KB) (into operation since 1 October 2015)

Annex 16

Certification by a Qualified Person and Batch Releasepdf(243 KB) (into operation since 15 April 2016)

Annex 17

Parametric Releasepdf(124 KB)
A revised version of Annex 17 is in preparation. On 15 September 2015, a consultation was launched on a draft revised Annex 17pdf(241 KB).
Further information on the consultation can be found here

Annex 19

Reference and Retention Samplespdf(24 KB)


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