Vol 4: GMP Human & Veterinary

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.


  • Introduction (07/02/2011)
  • 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


Annex 1

Manufacture of Sterile Medicinal Products

Annex 2

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

Annex 3

Manufacture of Radiopharmaceuticals

Annex 4

Manufacture of Veterinary Medicinal Products other than Immunological Veterinary Medicinal Products

Annex 5

Manufacture of Immunological Veterinary Medicinal Products

Annex 6

Manufacture of Medicinal Gases

Annex 7

Manufacture of Herbal Medicinal Products

Annex 8

Sampling of Starting and Packaging Materials

Annex 9

Manufacture of Liquids, Creams and Ointments

Annex 10

Manufacture of Pressurised Metered Dose Aerosol Preparations for Inhalation

Annex 11

Computerised Systems (revision January 2011)

Annex 12

Use of Ionising Radiation in the Manufacture of Medicinal Products

Annex 13

Manufacture of Investigational Medicinal Products

Annex 14

Manufacture of Products derived from Human Blood or Human Plasma (May 2011)

Annex 15

Qualification and validation (into operation since 1 October 2015)

Annex 16

Certification by a Qualified Person and Batch Release (into operation since 15 April 2016)

Annex 17

Parametric Release
A revised version of Annex 17 is in preparation. On 15 September 2015, a consultation was launched on a draft revised Annex 17.
Further information on the consultation can be found here.

Annex 19

Reference and Retention Samples


Other documents related to GMP