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

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

 

Introduction

    • 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.
  • 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

Part I – Basic Requirements for Medicinal Products

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

Part III - GMP related documents

Annexes

Table Eudralex
Annex 1 Manufacture of Sterile Medicinal Products
Annex 2 Manufacture of Biological Medicinal Products for Human Use
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)
Deadline for coming into operation: 30 November 2011

Annex 15 Qualification and validation
Annex 16 Certification by a Qualified person and Batch Release
Annex 17 Parametric Release
Annex 19 Reference and Retention Samples

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