The European Commission recently published a new version of compilation of
Community procedures on inspections and exchange of information ('Revised
Compilation of Community Procedures on Administrative Collaboration and
Harmonisation on Inspections', May 2001).
This compilation updates and replaces
document III/5698/94-EN 'Compilation of Community procedures on
administrative collaboration and harmonisation of inspection', worked out
by the Working Party on control of Medicines and Inspections in 1994. The
updated version has 86 pages and includes different guidelines that give
guidance for inspectors, e.g. on rapid alerts and procedures related to
GMP-inspections. This compilation also lays down a Community format for
the GMP Inspection Report and for the manufacturers authorisation and lays
down the content of batch certificates for drug or medicinal products that
are exported to countries under the scope of a MRA (Mutual Recognition
Agreement). Furthermore, the document gives guidance on exchange of
information between expectorates, and procedures related to
pre-authorisation inspections and to the preparation of reports on GMP
inspections requested by either the CPMP or CVMP in connection with
applications for marketing authorisations and with products authorised
under the Centralised System.
Some of the guidelines have already been
published and entered into force some years ago, e.g. the guideline
'Conduct of Inspections of Pharmaceutical Manufacturers' (1996) or the
guideline 'Training of Inspectors' (1996).
Other guidelines are quite new, e.g. the
guideline regarding the content of the fabricator's/manufacturer's batch
certificate for drug/medicinal products exported to countries under the
scope of a Mutual Recognition Agreement' (January 2001)
According to this guideline there will be
internationally harmonised requirements for the content of the batch
certificate of a drug/medicinal product. The importer of the batch is to
receive and maintain the batch certificate issued by the
fabricator/manufacturer. Besides general information about the name of the
product, the importing country, the marketing authorisation number, etc.,
results of analysis have to be documented and a certification statement
has to be given. The documentation of the analytical results should
include the authorised specifications, all results obtained and refer to
the methods used. The batch certificate has to be signed and dated by the
person responsible for releasing the batch for sale or supply and export.
This batch certificate is essential to exempt the importer from
re-control.
Another newer guideline as part of this
compilation describes the procedure for co-ordinating foreign and
Community pre-authorisation inspections during the assessment of
applications (January 2001). The legal basis for pre-authorisation
inspections of manufacturers of medicinal products in connection with the
granting of a marketing authorisation by the Community is laid down in
Article 8.2 of the Council Regulation (EEC) No 2309/93 that lays down
Community procedures for the authorization and supervision of medicinal
products for human and veterinary use and establishing a European Agency
for the Evaluation of Medicinal Products. The EMEA has a coordinating role
for theses inspections, but the responsibility for carrying them out rests
with the Supervisory Authority which is defined by legislation as the
'Competent Authority of the Member States' in which the product is either
manufactured or imported, controlled and released for the sale within the
European Economic Area.
The guidelines gives detailed information
about pre-submission notification by the applicant for a marketing
authorisation, designation of an inspection team and preparation for the
inspection, contacts with the applicant and the manufacturer(s) to be
inspected, inspection and transmission of the report and check on the
importer and submission of the final report to the Rapporteur and the
EMEA. The procedure described in this guideline ('Procedure for
Co-ordinating foreign and Community pre-authorisation inspections during
the assessment of applications') is included in The Rules Governing
Medicinal Products in the European Community, The Notice to Applicants,
Volume 2A, Procedures for
marketing authorisations.
For more details about each of the
guidelines, the complete compilation can be downloaded from the
EC-homepage (see 'News'
of 15/10/01).
Current Inspection Trends
Writer:
Dr. Barbara Jentges,
CONCEPT HEIDELBERG
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