Twenty-one professionals of the pharmaceutical industry took part in the workshop on risk analysis as applied to elaboration of environmental monitoring programs
Last week, FSI «SID & GP» and the Pharmstrategy company held the open expert and advisory workshop on the topic «Application of risk analysis to elaboration of environmental monitoring programs». The workshop was organized within the joint program of promoting implementation of the best practices in the Russian pharmaceutical industry.
At the workshop, 10 possible reasons for product contamination and possible ways of contamination risk realization were discussed. Environmental monitoring was mentioned as one of the effective tools to manage such risks. Besides, the risks of such monitoring itself were reviewed – such as non-representativeness and failures of the procedure, non-integrity of the data, insufficient documentation, etc. Such topics as investigation of root causes of deviations within environmental monitoring and CAPA elaboration were also covered.
The attendees appreciated the systematic approach to presenting the topic of environmental monitoring, including that to elaboration of monitoring programs based on risk analysis.
Learn more about the dates of upcoming workshops at the website www.goodpractices.ru.
- 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