The Ministry of industry and trade of the Russian Federation
FSI «SID & GP»
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Fifty experts of the pharmaceutical industry took part in the the expert-advisory workshop «Requirements and application of GMP rules for API manufacture»

At the end of December, experts of the State Institute of Drugs and Good Practices of Minpromtorg of Russia held an open expert-advisory workshop «Requirements and application of GMP rules for API manufacture» organized by FSI «SID & GP» and the Pharmstrategy company within the joint program of promoting implementation of the best practices in the Russian pharmaceutical industry.

Compliance with the requirements of Good Manufacturing Practice (GMP) in manufacture of active pharmaceutical ingredients (APIs) is one of the key factors of obtaining the drug of the required quality. This is why manufacture of APIs has always been under close attention both by manufacturing sites and regulatory authorities. Besides, GMP requirements as applied to APIs have certain peculiarities as compared to GMP requirements in terms of manufacture of finished dosage forms.

Within the workshop, lectures were provided by experts of the State Institute of Drugs and Good Practices of Minpromtorg of Russia: Ms. Madina Sottaeva, the Head of EAEU Pharmaceutical Inspectorates Cooperation Organization Department, and Mr. Vladimir Orlov, the Line Manager of EAEU Pharmaceutical Inspectorates Cooperation Organization Department. The methodological consultant and the leader of the workshop was General Director of the Pharmstrategy company Mr. Dmitry Sheyman.

«The audience of the workshop could get a better understanding of the requirements of the GMP-inspectorate for manufacture of active pharmaceutical ingredients and acquired valuable skills of tracing cause-and-effect relationship between the detected non-conformities with GMP, their root causes, hazards and possible negative consequences for the ultimate drug user», said Mr. Vladimir Orlov.

About 50 experts from pharmaceutical companies took part in the workshop: from quality control specialists, standardization and certification engineers to technology engineers and quality directors. Workshop participants emphasized the practical nature of the information based on hands-on experience of carrying-out inspections, the chance to get very direct and unambiguous answers to the questions related to certain sections of GMP from real inspectors and comprehend the interrelations within GMP rules.

At the workshop held, special attention was paid to consideration and a detailed analysis of regulatory documentation establishing the requirements for manufacture of active pharmaceutical ingredients in the Russian Federation and abroad. As a special topic, the most frequent non-conformities detected during regular GMP-inspections of API manufacturers were discussed. The audience highlighted the practical usefulness of the examples and cases presented at the workshop. The results of the work performed at the workshop will further be used by its participants in routine manufacturing activities.

As a result of the workshop, its participants outlined the problems having the utmost importance for consideration in future. The most important ones included the issues of risk analysis in design of API manufacture and planning of validation activities, determination of zone protection levels, audit of suppliers of starting materials and personnel training, documentation and assurance of compliance with the registration file, as well as a detailed discussion of real non-conformities detected during inspections.

By the end of the two-day workshop, its participants were ready to implement the knowledge acquired through intensive work. It means that the professionals are ready to apply risk analysis in design of new sites and involve employees of other subdivisions in risk analysis, as well as use the risk analysis methodology suggested at the workshop in routine activities. To be successful in hosting GMP-inspections, some companies are going to implement the so-called “self-inspections” and maintain the conscious competence in GMP among all personnel and subdivisions.