For a timespan of two years following the first GMP inspection of the Russian inspection authority GILS I NP on 12 April 2016, Indian pharmacy companies were the subject of most of the inspections. Since 2018, German manufacturers have moved into focus. This trend is expected to continue, which is why it is important for German pharmaceutical companies to know about the challenges of Russian GMP inspections.
The inspection process lies within the responsibility of the GILS i NP, in English: "The State Institute of Drugs and Good Practices". The application for the Russian GMP certificate must be submitted to the Ministry of Industry and Trade (Minpromtorg) of the Russian Federation, to which the GILS i NP is directly subordinate.
The average rate of failed Russian inspections is about 30 per cent. The rate is twice as high with small to medium sized pharmaceutical businesses as with international Big Pharma companies. However, big pharmaceutical companies which have European and American GMP certificates also frequently face statements by the Russian inspectors about irregularities. As a consequence, the issuance of the Russian certificate is denied by the Minpromtorg. The production of sterile pharmaceuticals is one of the main sources of problems. Among the most frequent findings are deviations concerning the aseptic production, the sampling of incoming raw materials, discrepancies from the approval dossier or insufficient / missing root cause analyses.
The GMP inspection must first be requested by the manufacturer. This includes the submittal of a list of documents to the Minpromtorg of the Russian Federation. The ministry must then examine these documents within 10 days. If no questions remain unanswered, the GILS i NP institute is commissioned with the inspection. A schedule is prepared by the institute and coordinated with the Minpromtorg. After the company is informed, a GMP inspection schedule is created which contains the elements of the production and quality control process to be inspected. 10 calendar days prior to the inspection, this Russian GMP inspection schedule is sent to the German pharmaceutical manufacturer, giving it the opportunity to prepare for the inspection. As part of the preparation, all relevant documents of the site must be translated into Russian or English. The site is visited by a minimum of two Russian GMP inspectors. Every inspected site is expected to provide a Russian interpreter, specialized on pharmacy and acting independently, for each GMP inspector. The number of inspectors depends on the production volume which is to be examined. On average, an inspection takes 3 to 5 days. If there are other pharmaceutical companies in the region, the Russian GILS i NP tries to conduct the GMP inspections as fast as possible.
Numerous documents have to be translated before every GMP inspection. Among these documents are SOPs, batch records, various documents concerning incoming goods, sampling, storage, production, quality assurance and quality control, packaging and logistics as well as job descriptions, delimitation agreements, qualification and validation documents and many more. In the case of remote GMP inspections, the Russian inspectors start with the examination of the documents and their translations, uploaded to the file server, prior to the GMP inspection. The GMP inspection itself, whether conducted on site or remote, starts with an opening meeting that has to be transferred into Russian by the translators / interpreters. The observations and results of the day are summarized at the end of every working day. The GMP inspection ends with a final meeting.
In the case of violations, the site representatives are informed during the GMP inspection at the final meeting. There is no classification of the observations. The GMP inspection report is completed within 30 calendar days after the end of the GMP inspection of the site. One copy of the report is sent to the company's representative in Russia, a second one rests with the GILS i NP and a third copy goes to the Minpromtorg, where the decision is made. Only non-conformities mentioned in the final meeting can be listed in the report. If open questions have been settled in the meantime, the respective documents have been subsequently submitted and CAPA has been implemented, the respective observations may be eliminated from the report. Upon completion of the inspection report, the approval authority of the manufacturer's home country is informed.
There is no fundamental difference between Russian GMP inspections and those from other countries. The Russian GMP inspectors ensure that the production at the inspected site is compliant with the valid Russian GMP regulations. They inspect all lines and facilities where a product intended for the Russian market is produced, filled or packaged.
Interpretations and approach of the GMP inspectors may vary, depending on their home country. There are certain national particularities, e.g. in the classification of violations. Whether a violation is classified as critical, major or minor depends on the qualification, experience and, as a result thereof, on the interpretation of each GMP inspector.
The production process is examined separately for each preparation, as requested by the manufacturer. It is important that only the products intended for the target country are included in the request, because only they should be inspected. Alexander Podarewski, Russian interpreter, remembers a case from his professional life where a misunderstanding led to the registration of all products made on the site for the Russian GMP inspection. Originally it should have been only two preparations listed for Russia. However, this was becoming clear only during the interpreting process in the GMP inspection. The Russian consulting company that submitted the request made a mistake in the translation of the communication: Instead of the two products relevant for Russia, all products made on the site were registered for the GMP inspection. The Russian GMP inspectors showed understanding for the translation error of the Russian consulting company. Nevertheless, all products had to be examined according to the request.
It must be ensured that pharmaceuticals delivered to Russia are safe for the country's citizens. One of the most frequent phrases after the opening of a GMP inspection is: "In addition to the compliance with GMP standards, we will make sure that you produce exactly what you announced in your request." While Russian GMP inspectors are known for their competence and fairness, they observe the compliance with all regulations very meticulously and with a certain strictness. All Russian inspectors have in-depth knowledge of the industry and are experienced in production, quality assurance or quality control. In most cases, they are professional pharmacists, chemists, biologists or microbiologists. The experienced Russian GMP inspectors are often supported by younger colleagues who surprise the "veterans" in many cases with their professionalism and experience in all aspects of the production process. From the experience of GMP interpreter and Russian translator Alexander Podarewski, a Russian GMP inspection is carried out in an objective and competent way, strictly following the formal requirements. It must be communicated to the GMP inspectors at any time that there are no secrets and that all answers are open and honest. In order to answer all questions asked by the inspectors, every pharmaceutical company facing a Russian GMP inspection is well advised to assign highly experienced employees.
No company can afford any risks when it comes to such an important matter as a GMP inspection. Interpreters are not exchangeable. A high degree of qualification and specialist knowledge is required for their work in the pharmaceutical field. This is why only professional GMP interpreters specialized in pharmacy are commissioned. Apart from a high linguistic and subject-specific competence necessary to master the complex contents, they must have sufficient experience and endurance. Only then will the GMP inspection be a success.