New GMP Initiative Published by EU Commission and EMEA

New GMP Initiative Published
by EU Commission and EMEA

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

This Concept Paper will update the guidance given in the GMP Guide on occasions when dedicated self-contained manufacturing facilities are required. The GMP guide will be revised to provide clearer guidance on this topic. This will involve Chapter 3, Chapter 5 and if necessary other chapters, and some of the annexes may need modification to maintain consistency. This new Guidance will take into account the principles and guidance currently being elaborated through ICH Q9 on quality risk management. A realistic timeframe for a text to be prepared for public comment is October 2005. Public consultation should occur over a 6-month period, and a finalised text could become operational in the third quarter of 2006.

It is very interesting that this Concept Paper already refers to ICH Q9 which is expected to be published within the next weeks. This emphasises the importance of the new ICH Q9 Guidance. The University of Heidelberg organises a conference on ICH Q9. Please visit www.gmp-conference.org for more information.

If you want to get more information on how to design and qualify pharmaceutical equipment and premises, we recommend the 4-day intensive training course "Pharmaceutical Engineering" in Barcelona.

You can download the Guidance if you click here.

The EU Commission Services present a draft of the new Guidance on the occasions when it is appropriate for Competent Authorities to conduct inspections at the premises of manufacturers of active substances used as starting materials. Article 111 of Directive 2001/83/EC, as amended by Directive 2004/27/EC, and Article 80 of Directive 2001//82/EC, as amended by Directive 2004/28/EC, include new provisions for inspections in this field. The Ad Hoc Working Group of GMP Inspection Services at the EMEA has developed this guidance as a harmonised approach for inspections under the amended EC legislation.

You can download the Guidance if you click here.

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

The draft revision only affects the introductory text (section 1) of the GMP Annex 18, which has been published on the Commission's website since 2001 implementing the Q7A guideline developed between the ICH partners EC, USA and Japan. No changes to the remaining sections 2-20 of the Annex are currently envisaged.

The Commission would like to emphasise that the document will be equally applicable to the veterinary sector. To take account of the needs of the veterinary sector, ectoparasiticides are excluded from the scope. Specific modifications, where identified for active substances to be used in veterinary medicinal products, can be developed in the GMP annexes 4 and 5 as appropriate. Changes refer to:

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

The Commission intends to publish the final version before 30 October 2005. Legal provisions for this guideline are vested in Article 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, as amended by Directive 2004/28/EC, for veterinary medicinal products.

Having the new developments in mind, we recommend the ICH Q7A Week in Basle in April. This Masterclass Course is supported by APIC/CEFIC. In total 12 GMP courses on GMP compliance can be booked separately or in combination.

You can download the proposal for section 1 if you click here.

The Commission publishes a draft format for the authorisations for manufacturing and import for public consultation. The Ad Hoc Working Group of GMP Inspection Services at the EMEA has developed the draft based on a format developed and published previously within the Compilation of Community Procedures.

The second draft document for public consultation refers to the GMP certificate for manufacturers. Within 90 days of an inspection, the competent authorities shall issue such 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 Recognition Agreements and has been adapted for application in all circumstances in which a GMP certificate is issued.

The Commission intends to publish the final version before 30 October 2005. Legal provisions for the form and content of the authorisation and the certificate of GMP are vested in Article 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, as amended by Directive 2004/28/EC, for veterinary medicinal products.

The current EU GMP requirements with regard to the Qualified Person will be covered at the European Conference:
The Qualified Person, 12-13 May 2005, Prague

The responsibilities within the Quality Assurance Unit (with regard to EU and FDA requirements) will be covered at:
EU GMP and FDA Compliance in QA Units, 13-15 April 2005, Prague

This Concept paper contains a proposal to revise Annex 14 of the GMP Guide which provides supplementary GMP guidance on the manufacture of medicinal products derived from human blood or plasma. The revision is necessary to take account of the regulatory changes brought about by Directive 2001/98/EC and its supporting technical directives which cover the collection and testing of blood and plasma whether for transfusion or for further processing to produce medicinal products. This work will be carried out in parallel with the development of good practice guidelines for blood and blood establishments expected to be developed by the Commission. You can download the Concept Paper if you click here.

Heidelberg, 11/03/2005

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