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GMP LOGFILE Features

2017-03-01

LOGFILE No. 08/2017 – Self-Inspection Q&A

Self-Inspection Q&A

(4 min. reading time)

by Dr. Doris Borchert and Dr. Sabine Paris

 

Do the authorities have to be granted access to internal audit reports during a GMP inspection?

Your question – our answer

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.

Your question:

Do the authorities have to be granted access to internal audit reports during a GMP inspection?

Our Sources in the GMP MANUAL:

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,

"Reporting:

  • It should be clearly evident that a report has been prepared and the recipients of the report should be identified.
  • The self-inspection report is not reviewed.
  • It should be evident that specified measures have been implemented.
  • An overview of the self-inspections conducted should be at hand.”

How are these regulations for inspectorates dealt with in practice?

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."

Our answer:

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.

LOGFILE-08-Self-Inspection_QA.pdf

Authors:

Dr. Doris Borchert and Dr. Sabine Paris
Maas & Peither AG - GMP-Verlag
Schopfheim, Germany
E-Mail: sabine.paris@gmp-verlag.de

 

Comments
Thank you GMP Manual team for this insight. This issue of reviewing self inspection reports of manufacturers in Nigeria has been a recurrent issue. Unfortunately, local regulations are ambiguos about this. I'll personally raise this with the authorities in our NRA with a view to review our regulations. Thank you.
Samson Fatoki 2017-03-02
 
Regarding your question "Can auditors/inspectors review internal audit reports", your answer rightly is that this is highly unusual. However I would point out a much deeper, frequently overlooked but more worrying situation - that involving civil law suits where one party claims that the other party did not follow GMPs. I have provided expert testimony in many such cases and I would advise that not only are internal audit reports typically secured by attorneys during a legal liability lawsuit, the documentation written is used in court cases, and the authors of the internal reports are typically deposed to provide evidence of either a company\\\'s wrong doing, or the company\\\'s lack of effective remediation of points discussed. I have been involved in such GMP related cases in Canada, France, Germany, Switzerland, the United Kingdom and the USA.
Michael Anisfeld 2017-03-29
 
 
 
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GMP Compliance Adviser
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Questionnaire for preparing GMP-inspections
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