GMP News No. 151
8 December 2001
New Version of Compilation of Community Procedures on Inspections and Exchange of Information
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).
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