Multiple foreign GMP inspections

Dear friends and colleagues,

Presently some one hundred countries practice foreign GMP inspections. As a result manufacturing sites, even those having a reasonable PQS, might be inspected many times per year by local and different foreign authorities. This leads to duplication of work and waste of recourses both by regulators and industry. A more detailed overview of the situation can be seen in the article GMP Inspection practice: a case for global benchmarking, convergence and mutual reliance/recognition.

Presumably this situation is related in part to the lack of mutual confidence between regulators. The reason for this may be differences, real or perceived, in expertise and/or resources between national inspectorates and also in local procedures in inspection practice.

Due to combined efforts by WHO, PIC-PIC/S and EU the practice of GMP inspections is largely harmonized between countries and regions of the World. At the same time national procedures still differ in many important aspects. Some examples are listed below:

  • Position of the inspectorate within the regulatory system
  • Financing method of the inspection function
  • Approaches to inspection of APIs manufacturers and to foreign inspections
  • Access of inspectors to self-inspection/internal audit reports
  • Review of inspection reports within the inspectorate
  • Recognition of GMP certificates issued by stringent regulatory authorities
  • Use of WHO Certification Scheme on the Quality of Pharmaceutical Products Moving in International Commerce.

Closer cooperation between regulators, information sharing and mutual recognition of inspection results by reliable inspectorates may allow to optimize the use of resources. For this, further convergence of GMP inspection procedures, as well as supporting legislation worldwide, is needed.

The opportunities of a closer cooperation in this area were recently discussed at several occasions. One may refer in this context to the 17-th International Conference of Drug Regulatory Authorities (ICDRA), Cape Town, S. Africa, 27 November-2 December 2016 (www.icdra.co.za). The document published by EMA in 2016 might also be mentioned (Connecting the dots. Towards global knowledge of the international medicine regulatory landscape: mapping of international initiatives. http://www.ema.europa.eu/docs/en_GB/document_library/Leaflet/2016/10/WC500214180.pdf).

As a first step in this direction, it is proposed to collect by means of a survey information on GMP inspection procedures in different countries (fill out the survey). Such a project might be regarded as an extension to annual surveys conducted by EFPIA.

It is understood that in principle such project ought to be conducted by an organization coordinating activities of regulators. Unfortunately according to information available GMP inspection procedures are not at present on the agenda of any international harmonization initiative in this area. Besides experience demonstrates that adequate information on the subject might be in a possession of other pharmaceutical sector professionals such as those involved in GR in the industry or in University level training programmes or in private sector consultancies. One example is the review Pharmaceutical Administration and Regulations in Japan prepared by the Pharmaceutical Manufacturers Association of Japan (JPMA) (http://www.jpma.or.jp/english/parj/whole.html and also http://www.nihs.go.jp/kanren/iyaku.html).

Colleagues willing to participate are not obliged to fill in all positions in the survey. Sharing of info related to any part of the attached form would be appreciated. On the other hand, data concerning one national regulatory system might be provided by two or more contributors. This will allow cross-checking of data received and eliminate subjective, or dubious entries.

It is planned to involve experts having experience with international harmonization initiatives for the analysis of returns. The outcome of the survey will be published or distributed as a report. All contributors will be acknowledged by names in the final text of the document. There are preliminary plans to offer the resulting document to a potentially interested international organization such as WHO, FIP or ICMRA for eventual use in development of global level documents on the issue.

The survey is being distributed to colleagues involved in recent years in conferences on Quality of Medicines organized by the Group VIALEK, to professionals in contact with Russian sectoral trade associations AIPM and ARFP, to subscribers to the journal “GMP News” as well as to a number of other colleagues knowledgeable in the issue.

A. Alexandrov
VIALEK

V. Fedorenko
GMP News

V. Shipkov
AIPM

V. Dmitriev
ARFP