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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.
- CONCEPT PAPER DEALING WITH THE NEED FOR
UPDATED GMP GUIDANCE CONCERNING DEDICATED MANUFACTURING FACILITIES IN THE
MANUFACTURE OF CERTAIN MEDICINAL PRODUCTS
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.
- Inspections at Manufacturers of Active
Substances - Guidance on Grounds (Triggers) for Inspection - for public
consultation
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.
- Detailed GMP guidelines for active
substances used as starting materials - public consultation
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.
- Authorisations for manufacturing and
import & GMP certificates - form and content for public consultation
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
- CONCEPT PAPER ON REVISION OF ANNEX 14 OF
EU GMP GUIDE
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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