Workshop MAIN REGULATORY REQUIREMENTS FOR GOOD DISTRIBUTION PRACTICE
A public counseling workshop on main regulatory requirements for good distribution practice took place on September 26, 2018.
The event was organized by the State Institute of Drugs and Good Practices (SID&GP) of the Russian Ministry of Industry and Trade together with PHARMSTRATEGY LLC. The workshop was an integral part of the joint project for promotion of the best practices in the Russian pharmaceutical industry. Alexei Zhilin, a senior expert of the SID&GP Department of Pharmaceutical Production Inspections, led the workshop activities and shared his experience with the audience.
The seminar was aimed at mastering best distribution practices rules, examining of real case scenarios, analyzing problems triggered by the introduction of GDP rules, and finding smart solutions. In addition to the GDP basic principles and specifics of their practical use, the workshop participants together with the experts practiced argumentation methods based on risk analysis for quality, helpful in communication with the inspecting agencies.
Galina Krapivnikova – First Vice President and Head of the Control and Pharmaceutical Administration of BIOTEK LLC noted great practical value of the workshop and recommended it for QMS specialists.
Leading pharmaceutical companies (Geropharm, Biochemist, Biotech, Canonpharma Production, Pharmasynthesis, and others) assigned their staff to attend the workshop.
- The workshop «Risk analysis in planning of validation at pharmaceutical manufacture»
- Fifty experts of the pharmaceutical industry took part in the the expert-advisory workshop «Requirements and application of GMP rules for API manufacture»
- A meeting with the professor of the Sechenov University was held in the State Institute of Drugs and Good Practices
- A meeting of the Council for Professional Qualification in Pharmacy was held in Moscow
- SID & GP – being ahead of time