GMP for medicinal products for human and veterinary use laid down in Commission Directives 91/356/EEC

TRADELABOR has more than 20 years of experience in the control and treatment of air, working with an experienced and qualified technical staff and with the most advanced technology in this area, which together guarantee the quality of the services provided.

 

 

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

  • IntroductionSearch for available translations of the preceding link (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.
  • Commission Delegated Regulation (EU) 2017/1569 (for linguistic versions, click here) of 23 May 2017 supplementing Regulation (EU) 536/2014 of the European Parliament and of the Council by specifying principles and guidelines for good manufacturing practice for investigational medicinal products for human use and arrangements for inspections (applicable as from the date of entry into application of Regulation (EU) No 536/2014 on Clinical Trials)
  • Commission Directive (EU) 2017/1572 (for linguistic versions, click here) of 15 September 2017 supplementing Directive 2001/83/EC of the European Parliament and  of the Council as regards the principles and guidelines of good manufacturing practice for medicinal products for human use (applicable as from the date of entry into application of Regulation (EU) No 536/2014 on Clinical Trials)

Part I – Basic Requirements for Medicinal Products

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

Part III – GMP related documents

Annexes

Annex 1 Manufacture of Sterile Medicinal ProductsSearch for available translations of the preceding link
Annex 2 New – Manufacture of Biological active substances and Medicinal Products for Human UseSearch for available translations of the preceding link (into operation since 26 June 2018)

Annex 2 is no longer applicable to Advanced Therapy Medicinal Products to which applies the Commission guideline on Good Manufacturing Practice for Advanced Therapy Medicinal Products, published in Part IV of Eudralex Volume 4 and operational as of 22 May 2018.

Annex 3 Manufacture of RadiopharmaceuticalsSearch for available translations of the preceding link
Annex 4 Manufacture of Veterinary Medicinal Products other than Immunological Veterinary Medicinal ProductsSearch for available translations of the preceding link
Annex 5 Manufacture of Immunological Veterinary Medicinal ProductsSearch for available translations of the preceding link
Annex 6 Manufacture of Medicinal Gases
Annex 7 Manufacture of Herbal Medicinal ProductsSearch for available translations of the preceding link
Annex 8 Sampling of Starting and Packaging MaterialsSearch for available translations of the preceding link
Annex 9 Manufacture of Liquids, Creams and OintmentsSearch for available translations of the preceding link
Annex 10 Manufacture of Pressurised Metered Dose Aerosol Preparations for InhalationSearch for available translations of the preceding link
Annex 11 Computerised SystemsSearch for available translations of the preceding link (revision January 2011)
Annex 12 Use of Ionising Radiation in the Manufacture of Medicinal ProductsSearch for available translations of the preceding link
Annex 13 Manufacture of Investigational Medicinal Products

Detailed Commission guideline of 8 December 2017 on the good manufacturing practice for investigational medicinal products pursuant to the second paragraph of the Article 63(1) of Regulation (EU) No 536/2014   (applicable as from the date of entry into application of Regulation (EU) No 536/2014 on Clinical Trials)

Annex 14 Manufacture of Products derived from Human Blood or Human PlasmaSearch for available translations of the preceding link (May 2011)
Annex 15 Qualification and validation (into operation since 1 October 2015)
Annex 16 Certification by a Qualified Person and Batch ReleaseSearch for available translations of the preceding link (into operation since 15 April 2016)
Annex 17 New – Parametric releaseSearch for available translations of the preceding link (Deadline for coming into operation: 26 December 2018)
Further information on the consultation can be found here.
Annex 19 Reference and Retention SamplesSearch for available translations of the preceding link

Glossary

Part IV – GMP requirements for Advanced Therapy Medicinal Products

Other documents related to GMP

Continue at:  https://ec.europa.eu/health/documents/eudralex/vol-4_en

The text above is owned by the site above referred.

Here is only a small part of the article, for more please follow the link

Also see:

www.manostaxx.com

 

Manostaxx
Manostaxx – Industrial Management Consulting

Leave a Reply

Your email address will not be published. Required fields are marked *