EU Online GMP Training Couses

Online GMP training courses focussed on the EU Good Manufacturing Practices for human and veterinary drugs and structured around the following specific EU GMPs and the links below.

The links are current as of 1st January 2016.

Introduction

  • Introduction(33 KB) or background to the EU GMPs.
  • 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

Annexes

Table Eudralex
Annex 1 Manufacture of Sterile Medicinal Products (122 KB)
Annex 2 Manufacture of Biological active substances and Medicinal Products for Human Use(171 KB) ((into operation since 31 January 2013)
Annex 3 Manufacture of Radiopharmaceuticals(68 KB)
Annex 4 Manufacture of Veterinary Medicinal Products other than Immunological Veterinary Medicinal Products(14 KB)
Annex 5 Manufacture of Immunological Veterinary Medicinal Products(43 KB)
Annex 6 Manufacture of Medicinal Gases (48 KB)
Annex 7 Manufacture of Herbal Medicinal Products(23 KB)
Annex 8 Sampling of Starting and Packaging Materials(20 KB)
Annex 9 Manufacture of Liquids, Creams and Ointments(13 KB)
Annex 10 Manufacture of Pressurised Metered Dose Aerosol Preparations for Inhalation(17 KB)
Annex 11 Computerised Systems (revision January 2011) (22 KB)
Annex 12 Use of Ionising Radiation in the Manufacture of Medicinal Products(50 KB)
Annex 13 Manufacture of Investigational Medicinal Products(67 KB)
Annex 14 Manufacture of Products derived from Human Blood or Human Plasma(50 KB) – May 2011
Annex 15 Qualification and validation(95 KB) (into operation since 1 October 2015)
Annex 16 Certification by a Qualified person and Batch Release Current(41 KB)  Deutsch (de) ελληνικά (el) español (es) français (fr) italiano (it) Nederlands (nl) Deadline for coming into operation: 15 April 2016 (243 KB)
Annex 17 Parametric Release(124 KB) A revised version of Annex 17 is in preparation. On 15 September 2015, a consultation was launched on a draft revised Annex 17(241 KB). Further information on the consultation can be found here
Annex 19 Reference and Retention Samples(24 KB)

Other documents related to GMP

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