ASENMCO arranges annual conferences on Technology of Cleanliness and GMP Rules. 23 Conferences were held since 1991, which gathered a lot of specialists.
The XVIIIth ASENMCO Conference was held on 24 November 2008.
Presentations at the XVIIIth conference:
- New GMP and Cleanrooms standards. Developments of GMP Rules. Draft GOST R 52249-2009 (GMP).
А. Е. Fedotov Федотов, president ASENMCO
- System of the State Control for manufacturing of medicinal products. Inspections of domestic and foreign plants. Typical disadvantages.
А. E. Gabidova, Head of Department for State Control of manufacturing of medicinal products, Roszdravnadzor
- Design of facilities for manufacturing of medicinal products.
V. D. Yakukhina, Head technologist of company «Invar-project»
- Domestic Air filters. Standards on Air filters:
– GOST R EN 779-2007 Particulate air filters for general ventilation,
– GOST R 51251-1999 Air filters. Classification. Marking,
– Draft GOST R EN 1822-1 High efficiency air filters (HEPA and ULPA). Part 1: Classification, performance testing, marking.
O. V. Provolovich, Technical Director of company «Folter»
- Quality assurance system. GMP inspections (audit) of cleanrooms and plants in Russia and abroad. Certification and qualification of cleanrooms and plants on GMP compliance. Typical mistakes.
GOST R ISO 14644-3 «Cleanrooms and associated controlled environments. Part 3. Test methods».
A. E. Fedotov, president ASENMCO
- Cleanroom testing instruments.
D. A. Larin, Head of Clearoom testing laboratory
- Quality assurance system: difficulties and experience. GMP documentation.
I. A. Gert, Head of Quality assurance department of company «Canonpharma production»
- Problems of development of pharmaceutical industry of Russia
A. V. Buran, Advisor of Healthcare department of Moscow government
- Cleanroom garmants
A. A. Tarakanov, director of company «Laboratory of technological garments»
- Maintenance of cleanroom garments. Laundries.
Micky Hesse, Company «Uniclean»
- New standards:
– GOST R EN 13779-2007 Ventilation for non-residential buildings – Performance for ventilation and room-conditioning systems,
– GOST R ISO 14644-7-2007 Cleanrooms and associated controlled environments. – Part 7: Separative devices (clean air hoods, gloveboxes, isolators and minienvironments),
Prof. A. Ya. Najdyonov, OAO «Biochimmash»
XIX ASENMCO conference
The XIX ASENMCO conference was held 12-13 October 2009 in Moscow.
Presentation of the Russian national standard GOST R 52249-2009 «Good manufacturing Practice for Medicinal Products» (GMP) was the key event of the conference. This standard is equipment to GMP EC Guide 2009.