In our GMP
News of 20 September 2005 we informed you about the chapter
"Inspections" of the EMEA document "Compilation of community procedures
on inspections and exchange of information". It is the objective of
this document to enable harmonised official inspections in the EU.
This document is complemented by an SOP issued by EMEA, which describes
the harmonisation and conduct of GMP- and product-/process-related
inspections of an application for marketing authorisations under the
centralised system ("Procedure
for co-ordinating pre-authorisation GMP and product/process- related
inspections").
By means of highly detailed lists, this SOP describes the correct
procedures for the topics "Pre-submission Meetings", "Validation
of the application by Inspections Sector", "Submission and
GMP compliance", "Preparation of GMP Inspection Request",
"Pre-authorisation Sampling and Testing", "Initiation of a GMP
Inspection and/or Sampling and Testing" and "Inspections reports".
This list of actions is complemented by a column titled
"Responsibility".
Even though this SOP has, of course, been written for authority
representatives, it is worthwhile reading also for members of the
pharmaceutical industry. The column "Responsibility" lists e.g.
also the person handing in the application or the firm to be inspected.
Besides, the procedure for writing the report is described in detail. Flow
charts help to illustrate the whole way of proceeding. Another table list
the individual steps once more for post-authorisation inspections -
including the necessary intervals for re-inspections. This table is also
very helpful, as it shows in which periods the pharmaceutical companies
have to prepare for inspections.
Summary: This SOP shows EMEA's internal procedures for inspections
triggered by applications for a central marketing authorisation, e.g. for
biotechnological products.
|
