New GMP Initiative Published by EU Commission and EMEA

GMP News No. 530

11 March 2005

New GMP Initiative Published
by EUCommission and EMEA

The Commission has published severaldocuments for consultation on their website. These documents will revisesome existing GMP requirements and also add some new requirements.


This Concept Paper will update theguidance given in the GMP Guide on occasions when dedicated self-containedmanufacturing facilities are required. The GMP guide will be revised toprovide clearer guidance on this topic. This will involve Chapter 3,Chapter 5 and if necessary other chapters, and some of the annexes mayneed modification to maintain consistency. This new Guidance will takeinto account the principles and guidance currently being elaboratedthrough ICH Q9 on quality risk management. A realistic timeframe for atext to be prepared for public comment is October 2005. Publicconsultation should occur over a 6-month period, and a finalised textcould become operational in the third quarter of 2006.

It is very interesting that this ConceptPaper already refers to ICH Q9 which is expected to be published withinthe next weeks. This emphasises the importance of the new ICH Q9Guidance. The University of Heidelberg organises a conference on ICHQ9. Please visit for more information.

You can downloadthe Guidance if you click here.

  • Inspections at Manufacturers of ActiveSubstances - Guidance on Grounds (Triggers) for Inspection - for publicconsultation

The EU Commission Services present adraft of the new Guidance on the occasions when it is appropriate forCompetent Authorities to conduct inspections at the premises ofmanufacturers of active substances used as starting materials. Article 111of Directive 2001/83/EC, as amended by Directive 2004/27/EC, and Article80 of Directive 2001//82/EC, as amended by Directive 2004/28/EC, includenew provisions for inspections in this field. The Ad Hoc Working Group ofGMP Inspection Services at the EMEA has developed this guidance as aharmonised approach for inspections under the amended EC legislation.

You can download the Guidance ifyou click here.

  • Detailed GMP guidelines for activesubstances used as starting materials - public consultation

The EU Commission presents a draft of thedetailed guidelines on the principles of good manufacturing practice foractive substances used as starting materials.

The draft revision only affects theintroductory text (section 1) of the GMP Annex 18, which has beenpublished on the Commission's website since 2001 implementing the Q7Aguideline developed between the ICH partners EC, USA and Japan. No changesto the remaining sections 2-20 of the Annex are currently envisaged.

The Commission would like to emphasisethat the document will be equally applicable to the veterinary sector. Totake account of the needs of the veterinary sector, ectoparasiticides areexcluded from the scope. Specific modifications, where identified foractive substances to be used in veterinary medicinal products, can bedeveloped in the GMP annexes 4 and 5 as appropriate. Changes refer to:

  • The structural implementation in the GMPguide as Part II of the "Basic Requirements" instead of Annex18. The current "Basic Requirements" of the GMP guide willbecome Part I in the future. The remaining annexes will supplement bothPart I and Part II as appropriate, and a programme to review the guidancealready given on active substances in annexes 2-7 is being undertaken.EMEA will publish a Concept Paper on this shortly.
  • Section I "Introduction" to theexisting Annex 18 (the future Part II of the basic requirements)
  • Specific exclusion of veterinaryectoparasiticides

The Commission intends to publish thefinal version before 30 October 2005. Legal provisions for this guidelineare vested in Article 47 of Directive 2001/83/EC, as amended by Directive2004/27/EC, for human medicinal products and Article 51 of Directive2001/82/EC, as amended by Directive 2004/28/EC, for veterinary medicinalproducts.

You can download the proposal forsection 1 if you click here.

  • Authorisations for manufacturing andimport & GMP certificates - form and content for public consultation

The Commission publishes a draft formatfor the authorisations for manufacturing and import for publicconsultation.The Ad Hoc Working Group of GMP Inspection Services at the EMEA hasdeveloped the draft based on a format developed and published previouslywithin the Compilation of Community Procedures.

The second draft document for publicconsultation refers to the GMP certificate for manufacturers.Within 90 days of an inspection, the competent authorities shall issuesuch a certificate, if compliance with GMP requirements can be confirmed.Member States will have to implement these provisions by 30 October 2005.The format is based on that used in connection with the Mutual RecognitionAgreements and has been adapted for application in all circumstances inwhich a GMP certificate is issued.

The Commission intends to publish thefinal version before 30 October 2005. Legal provisions for the form andcontent of the authorisation and the certificate of GMP are vested inArticle 47 of Directive 2001/83/EC, as amended by Directive 2004/27/EC,for human medicinal products and Article 51 of Directive 2001/82/EC, asamended by Directive 2004/28/EC, for veterinary medicinal products.


This Concept paper contains a proposal torevise Annex 14 of the GMP Guide which provides supplementary GMP guidanceon the manufacture of medicinal products derived from human blood orplasma. The revision is necessary to take account of the regulatorychanges brought about by Directive 2001/98/EC and its supporting technicaldirectives which cover the collection and testing of blood and plasmawhether for transfusion or for further processing to produce medicinalproducts. This work will be carried out in parallel with the developmentof good practice guidelines for blood and blood establishments expected tobe developed by the Commission. You can download the Concept Paper if youclick here.

Heidelberg, 11/03/2005




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