A regular educational course for pharmaceutical inspectors is taking place at FSI «SID & GP»
On 04 February, 2019, the State Institute of Drugs and Good Practices started a regular educational course for GMP inspectors (theory and practice) including the topical issues of Good Manufacturing Practice. This course is mandatory for the pharmaceutical inspectorate and lasts 2 months.
In the period from 04 to 08 February, the following topics from the GMP environment are under focus:
- Training and attestation of Qualified Persons in the Russian Federation and the EAEU;
- Chapters 3 and 5 of EU GMP and EAEU GMP with revisions as of 2015;
- Cross-contamination risk assessment in shared (multi-purpose) facilities;
- Cleaning validation in shared (multi-purpose) facilities;
- Manufacture of sterile drugs with a brief discussion of the draft of revisions in Annex 1 to EU GMP.
Apart from the theoretical part, the workshop includes case studies related to detection and classification of GMP non-conformities during GMP inspections.
An increased focus is put on the analysis and comparison of certain paragraphs of the requirements contained in the effective RF GMP, EU GMP and EAEU GMP, as well as in the recommendations by global professional associations in the pharmaceutical manufacture environment.
The workshop features the following speakers:
- EU experts-certified GMP professional and trainer, Doctor of Pharmacy, Professor Yury Podpruzhnikov.
- Deputy Director for Scientific Activities, Department Head in Sechenov University, Doctor of Pharmacy, Professor Natalia Pyatigorskaya.
- 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