Europe's Answer to the FDA Investigational Manual

GMP News No. 227

GMP News
27 August 2002
 

Europe's Answer to the
FDA Investigational Manual

 
The FDA Investigational Manual is often the focal point of attention. It contains detailed instructions for the conduct of FDA inspections. Therefore, this document is of interest to all those who are subject to FDA inspections. You will find the document if you click here.

Since May 2001, a revised EU document with very similar contents has led a quiet existence (and was published on the Internet in October 2001): the "Compilation of Community Procedures on Administrative Collaboration and Harmonisation of Inspections". This compilation of 86 pages contains among others information on:

  • Conduct of Inspections of Pharmaceutical Manufacturers
  • GMP Inspection Report - Community Format
  • Content of the Fabricator's/Manufacturer's Batch Certificate for Drug/Medicinal Products Exported to Countries under the Scope of a Mutual Recognition Agreement (MRA)

  • Procedure for Co-ordinating Foreign and Community Pre-authorisation Inspections during the Assessment of Applications

  • Especially the description of how to conduct a GMP inspection (see page 15 following) offers a lot of useful information for pharmaceutical manufacturers.

    In this document, you can also find the following activity/decision diagram for inspections on the basis of applications under the centralised system.

    The topic "complaints" has been examined closely in this document - like in the FDA Investigational Manual. On the one hand in the context of the Rapid Alert System, which is described in the first part of the above document, on the other hand within the description of the conduct of GMP inspections, where it says under point 19:

    Complaints and product recall: the system for recording and reviewing complaints as well as the system for recalling batches of medicinal products from within and outside the Member States should be examined during the inspection.

    The complaints file should be examined. Defect reports and recalls should be discussed.

    If you would like to download the "Compilation of Community Procedures on Administrative Collaboration and Harmonisation of Inspections", please click here.

    Author:
    Oliver Schmidt
    CONCEPT HEIDELBERG

      

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