Inspections of pharmaceutical production sites for compliance with GMP standards are an integral part of the drug quality assurance system. The Pharmaceutical Inspectorate of the Russian Ministry of Industry and Trade discussed the specifics of an inspector’s work, along with the factors that help enhance the quality culture at both Russian and foreign sites, in a conversation with GxP News.
1 Inspector’s Area of Responsibility
An inspector’s core function is to conduct pharmaceutical audits to verify a pharmaceutical manufacturer’s compliance with the GMP rules. The inspector is responsible for ensuring the entire inspection process is accurate, objective, and impartial, as well as for the interpretations and conclusions contained in the report.
2 Education Needed to Become an Inspector
To conduct GMP inspections properly, a candidate must meet the education, qualification and work experience requirements set by the quality system of the Russian Ministry of Industry and Trade’s GMP Inspectorate. These requirements are typically aligned with, or exceed, those established by the Eurasian Economic Union for the authorized personnel of drugs manufacturers.
A prospective inspector must have a specialized degree in biology, chemistry, pharmacy, biotechnology, or medicine, with relevant experience also being a crucial aspect. Typically, these are specialists with a background in manufacturing, quality control, and/or quality assurance. All hired personnel are required to complete an intensive training program that includes theoretical preparation, practical sessions, and participation in inspections under the guidance of experienced mentors.
3 Should an inspector possess any specific knowledge and skills?
Beyond professional knowledge, an inspector must have analytical thinking, be disciplined, and maintain composure in any situation. The ability to work in a team is particularly important, regardless of whether one is a lead inspector or a member of an inspection team. This ensures coordinated and effective work during the inspection and the formulation of objective findings.
4 Is periodic assessment of an inspector’s knowledge conducted?
The quality system of the Russian Ministry of Industry and Trade’s GMP Inspectorate aims to ensure the uniformity and high standard of inspections. This is achieved, among other things, through the continuous training and skill enhancement of inspectors. For this purpose, a dedicated training system for GMP inspectors has been established and is now operational. It encompasses a comprehensive set of tools for developing additional professional skills necessary for effective and rational inspector performance. Various training formats are used—lectures, webinars, case studies, business games, including simulations of various inspection scenarios. The professional competence of pharmaceutical inspectors is regularly analyzed to identify any need for further training and to shape the development strategy of the Russian Ministry of Industry and Trade’s GMP Inspectorate.
5 How are inspectors perceived at manufacturing sites?
Typically, companies that understand that the inspector’s work directly impacts the quality of manufactured medicines perceive a GMP inspection as an opportunity to improve their existing pharmaceutical quality system. They value the chance to see their production through the eyes of a GMP inspector and identify weaknesses in the system. This helps to reduce quality risks and enhance production reliability. When non-conformities are observed and identified, the manufacturer takes appropriate measures and develops an action plan aimed not only at eliminating the non-conformities but also at preventing their recurrence. Sites strive to assess, and address identified non-conformities in the shortest possible time. The shared goal is to ensure that medicines are manufactured in a way that guarantees their quality and safety for patients.
6 What are the timelines for sites to eliminate non-conformities?
In accordance with the Rules for Conducting Pharmaceutical Inspections approved by the Decision of the Council of the Eurasian Economic Commission dated November 3, 2016, No. 83, a site must submit a response no later than 60 calendar days from the date of receiving the first part of the report containing the list of non-conformities. This response must include a plan of corrective and preventive actions, a report on its implementation, and data confirming the elimination of the identified non-conformities. Therefore, the time allocated to eliminate non-conformities, considering the deadline for submitting the response, is less than 60 calendar days.
7 Which legislative initiatives are most significant for the industry?
In the near future, amendments will be introduced to Appendix 1 of the Union’s Good Manufacturing Practice Rules (Union GMP Rules) concerning the manufacture of sterile medicines. Additionally, supplements to the Union GMP Rules dedicated to the manufacture of advanced therapy medicinal products (ATMPs) are being prepared; these will form a separate, fourth part of the Union GMP Rules.