Inspectors of the State Institute of Drugs and Good Practices of FSI “GILS and NP” raise their qualifications in proper distribution practices
The members of the State Institute of Drugs and Good Practices, inspecting foreign production sites for compliance with the standards of good manufacturing practices, are now being trained in distribution practices (GDP) at the Educational Center “SID&GP”. The advanced training program started on November 27, 2016 and will end at the end of January 2017.
This is the first training program in distribution practices (GDP), prepared and conducted by specialists of the Educational Center. The senior teacher was Yury Vasilyevich Podpruzhnikov, Doctor of Pharmaceutical Sciences, Professor, certified by experts of the EU and an expert in GMP / GM.
As a result of the training participants will receive the competencies necessary to inspect drug distributors in accordance with the current regulatory legal acts of the EAEU and individual states, members of the Union. Such inspection (audit) may take place during distribution, storage, transportation, wholesale, import, export and other stages of the circulation of medicines.
The good distribution practice (GDP) is a part of the quality assurance system that guarantees the quality of medicines (drugs) at all stages from the manufacturer to the entities that sell or dispense medicines to population.
GDP requirements are applicable to wholesale distributors, as well as partly to drug manufacturers and brokers. All of them must conduct their activities in accordance with this standard. Fulfillment of the rules of GDP ensures that the supplied drugs maintain quality and are not falsified during storage and transportation. That is why it is so important to improve the skills of inspectors in this area continuously.
The training began with an assessment of the input level of knowledge of students. The lectures alternated with practical exercises and trainings in which participants could study various aspects of the warehouse operation in accordance with the standards of GDP / GSP. These are practical exercises on the layout of warehouse premises, at the choice of (qualifications) of suppliers and buyers, acquaintance with measuring equipment for measuring temperature, humidity, light, as well as drawing up a plan, protocol and report on the temperature map of a warehouse, training on organizing and conducting inspections for compliance GDP requirements with documentation and so on. In the field of GDP, trainees gained knowledge on quality management, documentation, contract operations, transportation, claims, returns and many other important points.
Participants had the opportunity to get information about the system of state registration of medicines as the part of the course, the pharmacovigilance system and the system of state quality control of medicines during their circulation, as well as the legal regulation of the circulation of medicines in the EAEU member states.
The first part of the training course lasted five days and ended with intermediate tests that showed a real improvement in the quality of knowledge of the students. Training will continue during December and January. Part of the classes will be held remotely, visits to distributors warehouses are expected during the course. In total, the program consists of 172 academic hours. Based on the results, a certificate of professional development will be issued.
- The Director of SID & GP opened a new manufacturing site in Nizino
- Export potential of Russian pharmaceuticals has been discussed at the SPIEF
- By 2022, SID & GP will have developed several pediatric dosage forms
- Good practices in drug quality assurance from development to the consumer
- GMP inspectorates of Russia and Uzbekistan signed an Agreement on Cooperation