Participation in the XV conference «Actual problems of quality assurance of medicinal and medical care»
On July 3-5, 2018 in Sochi, representatives of the FSI «SID & GP» took part in the XV anniversary annual interregional conference «Actual problems of quality assurance of medicinal and medical care.» Welcoming speech on behalf of the Institute was made by Vladislav Shestakov, Director of the FSI «SID & GP».
«In 2018, we, as direct participants in pharmaceutical processes, face many challenges. Gradually the end of the implementation of the Pharma-2020 program is coming to an end, the foundation of ideas and plans for the Pharma-2030 is laid. At the events of our industry, the results of this decade are gradually being summed up, much has already been done. And there are a number of other issues that need to be addressed to one degree or another. This set of results and not yet fully developed fields for development, we will discuss in the course of this event. The spectrum of «agendas» is truly diverse, it covers both global issues of the pharmaceutical market and private but equally important issues – issues of access to medicines, electronic bidding, the specifics of hospital pharmacies, the finer points of drug testing, pharmaceutical counseling and much more», noted Vladislav Shestakov in his speech.
At the round table «GMP-inspections took place, what’s next?» Ivan Gulyaev, chief specialist of the inspection department for the production of medicines of the FSI «SID & GP», spoke. The main topic of the report was the preparation for the recurrent GMP-inspection and its stages:
- analysis of identified non-conformities during previous inspections;
- development, active implementation of CAPA and evaluation of their effectiveness;
- initiation of the procedure of the recurrent inspection, including the submission of a set of documents for examination.
According to Ivan Gulyaev, when applying for a second/ recurrent inspection, special attention should be paid to the readiness of the production site, taking into account the correction of all nonconformities and the introduction of appropriate changes. Developed and implemented CAPA must undergo appropriate expertise, be justified and sufficient, in addition, it is necessary to assess their effectiveness. Assessment of the readiness of the production site for inspection includes confirmation of the availability of a production base (personnel, premises, equipment, quality control of drugs, etc.) and the availability of proper documentation.
- The Formulary of Russian pharmaceutical manufacturers by SID & GP is a tool much in demand by the industry
- A business meeting between the EAEU’s ISPE and the senior management of ISPE was held in Dublin
- Based on the results for 2018, 0.11% is the share of the drugs imported from Latin America
- The Russian GMP inspectorate signed an Agreement on Cooperation with the Cuban CECMED
- The Russian «Data Integrity & Computer System Validation» Guidelines were presented at the ISPE session