GMP inspection of foreign manufacturers. Common problems and their solutions.

 Author: Sokolova Elena Borisovna, a leading specialist in GMP inspection.

In this article we will talk about a hot issue: how to successfully pass the inspection and get the coveted GMP certificate of the Ministry of Industry and Trade.

The main problem of manufacturers is  poor preparation for inspection. And this does not mean that it is about the poorly organized quality control system at the production site. This means that the manufacturer does not know how Russian inspectors check the production site and what they want to see there.

The list of documents for submitting an application for GMP inspection by the Ministry of Industry and Trade is quite small: it is a formal letter with applications and SMF (site master-file), or the main file of the site. However, in reality, during inspection, a much larger amount of documentation is checked: SOPs (standard operating procedures), quality guidelines, risk management, deviation investigation records, a list of approved suppliers, and personnel hygiene documents, and many other things.

Thus, if a manufacturer intends to be inspected successfully from the very first time, he should be well prepared, and this is almost impossible to do without engaging a consulting company that is well acquainted with Russian realities.

The situation is even more interesting for manufacturers whose products are already registered in Russia. They face all the same requirements as the “newcomers”, plus the inspectorate pays special attention to the documentation for medicines already registered in Russia at the moment. And here it is necessary to understand that the issuer of quality control for an industrial series of drugs intended for Russia must fully comply with the registered ND. It means that, the quality must be controlled in all respects, and the methodologies should be the same.

A few general points here:

  1. To the application for the inspection we attach a list of drugs which are supposed to be inspected. The more drugs are stated in the application, the more risks and more questions the experts will ask. Therefore, it is necessary to think carefully and evaluate how reasonable this or that drug is to be included in the list.
  2. During the inspection, it is very important to have a good translator who knows the pharmaceutical industry from the inside and can precisely explain all the “bottlenecks”, the one who understands what they say and, therefore, convey the necessary information to the experts correctly.
  3. After the inspection, the applicant has a limited amount of time (about 10 days) to submit additional materials at the request of an expert. And, obviously, if there are a lot of comments, then there is simply no time to prepare high-quality answers.

Summing up, I can say that, based on RegMed’s experience, it’s impossible to hope for this opportunity and the most correct thing here is to prepare in the best way for the inspection from the outset, having given it enough time and attention. It also makes sense to organize a preliminary audit, during which highly qualified inspectors will identify shortcomings of quality control systems (or their non-compliance with Russian standards) and help to eliminate them even before the official visit of inspectors from the Ministry of Industry and Trade. As our practice shows, this approach guarantees a positive result.

Regulatory framework:

1) The rules for organizing and conducting inspections of drug manufacturers for compliance with the requirements of the rules of good manufacturing practice, as well as issuing conclusions on the compliance of the drug manufacturer with the specified requirements (Government Decree No. 1314 of 03.12.2015).

2) Administrative regulations on the state services provision  for the issuance of GMP certificates.

(the Order of the Ministry of Industry and Trade N 1714 dated May 26, 2016).