At the editorial office of GMP-Publishing we receive a steady stream of interesting questions from our readers on GMP regulations and their practical implementation. Last week the important and quite controversial question was asked concerning whether or not GMP inspectors must be granted access to self-inspection reports of pharmaceutical manufacturers.
In today’s article we have compiled all available information from the GMP MANUAL and the GMP-BERATER together with commentaries on the topic by GMP inspectors from our team of authors. This will provide you as a LOGFILE subscriber with up-to-date information, at the same time giving you an inside look at the activities of our editorial staff.
Dr. Christian Gausepohl writes about this topic in Chapter 18.F.7 "Self-Inspection":
"The authorities do not usually check the self-inspection documents without having a good reason. This is defined in the Guidance for FDA Staff and Industry: Compliance Policy Guide, Sec. 130.300, for example. The reason for this is that companies should be encouraged to carry out honest and intensive self-inspections. Disclosure during a customer audit can also be waived. It is recommended that the approach be described in the SOP. Whether it has been confirmed that a self-inspection was carried can be checked during an inspection or customer audit. For this reason, the documents should be structured in a particular way, e.g. a separate page should be used for confirming that the self-inspection has been carried out or the approval page should be presented."
Answers to the question posed above may also be found in the Regulations part of the GMP MANUAL and of the GMP-BERATER, respectively.
The Compilation of Community Procedures on Inspections and Exchange of Information (CoCP) is a European collection of standard operating procedures for the body of EU GMP inspectors. Its purpose is to promote cooperation and harmonisation within EU authorities and it serves as a basis for national QA systems of GMP inspectorates. The Procedure Conduct of Inspections of Pharmaceutical Manufacturers or Importers (GMP MANUAL Chapter C.10.1) item 4.8 states:
"Self-Inspection: the system for performing self-inspections in the company should be examined, although the reports themselves should not normally be read by the inspector."
SOPs on a national level which take the contents of the CoCP into consideration have been published in the QA system for GMP inspectorates by the (German) Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten (ZLG) (Central Authority of the Länder for Health Protection with regard to Medicinal Products and Medical Devices). According to Section 3.5.3 of the SOP for the GMP inspectorates of the German federal states (Bundesländer), VAW 071102 Vorbereitung, Durchführung und Nachbereitung von Inspektionen im Bereich GMP (SOP 071102, Preparing for, Conducting and Following up on GMP inspections) (GMP-BERATER Chapter C.3) with regard to checking the documents:
"A particular part of general GMP inspections involves checking the following documents: [...] the system for conducting self-inspections within the company (without looking into details of the self-inspection protocols)."
Also in the Aide-mémoire 071201 Überwachung von Arzneimittelherstellern (GMP-BERATER Chapter D.4) (Aide-mémoire 071201 on monitoring pharmaceutical manufacturers) issued by the ZLG there are clear regulations on dealing with self-inspection results. For example, in Section 9 on self-inspections,
We asked two GMP inspectors from the GMP MANUAL team of authors to answer this question. They both agree:
"It is not common practice among inspectors to review the detailed protocols of the self-inspection, but very much so to trace the procedure, including the inspected areas, and the timely elimination of deficiencies. If the authority actually expresses the wish to inspect the reports (even though this is not customary), this request may not be denied."
Not only the QA regulations for GMP inspectors, but also actual inspection practice have provisions for reviewing the system for conducting self-inspections; however, the relevant protocols are not inspected. Exceptions may be made only if there is a good reason for doing so.
Dr. Doris Borchert and Dr. Sabine Paris
Maas & Peither AG - GMP-Verlag