The European Medicines Agency (EMA) has updated its GMP facility inspection procedures to align with recent revisions to its EU GMP Guide reflective of ICH Q8-10 principles.
In the revised document, wording has been added to recommend the use of risk-based planning for inspections and to clarify the scope and application of inspections of importers. In addition, the EMA has added an annex on conducting inspections of active substance manufacturers.
The new version of this guidance is more comprehensive and prescriptive than the 2006 version, suggesting specific documents and procedures for GMP inspectors to evaluate, and providing recommendations on how to conduct the wrap-up meeting.
The new drug substance inspection annex is intended to “harmonize inspection procedures, frequency of inspections and follow-up procedures, thus ensuring a consistent approach to assessment and decision-making by Competent Authorities” in line with current EC Directives.
The annex advises member states to establish the legal and administrative framework needed for identification of facilities, access to facilities and data, and GMP inspections of active substance manufacturers and importers, including sites which only repackage or re-label active substances. Detailed procedures using a quality systems approach which are consistent with EU-level documents need to be established by member states to ensure site compliance with GMPs and with European Pharmacopia monographs where applicable. Sufficient resources should also be available and trained to conduct the inspections, according to the annex.
The sterilization and aseptic processing of sterile active substances are not covered in this annex. Whole blood and plasma are also excluded. However, active substances that are produced using blood or plasma as raw materials are included.
FDA has also been updating its inspection guidance, including the compliance program guide for pre-approval inspections, to reflect a more risk-based/ICH Q8-10 approach, (see IPQ “In the News” May 12).
[Editor’s Note: The June issue of IPQ will provide an in-depth report on the changing inspection and GMP enforcement landscape in the US, EU, and globally.]