The Ministry of industry and trade of the Russian Federation
FSI «SID & GP»
+7 (495) 676-43-60 109044, Moscow, Lavrov lane., 6

Robert Tribe, Advisor to PIC/S, conducted a consulting audit of the Russian GMP Inspectorate

Since September 23, Robert Tribe had conducted a consulting audit of the Russian GMP Inspectorate. The audit was held in the framework of a joint application of the Minpromtorg of Russia and FSI “SID and GP” to join the PIC/S (Pharmaceutical Inspection Co-operation Scheme). Since January 1, 2018 PIC/S will unite 52 countries around the world.

Within the consulting audit framework regulatory practices, legislation, enforcement norms and rules, internal documents of the Russian GMP Inspectorate have been assessed. The current level of GMP inspection has been highly evaluated, along with this zones of the Russian legislation and law enforcement practices development and harmonization with the rules of the PIC/S member countries have been indicated. Special attention has been paid to the interdepartmental interaction of all participants in the pharmaceutical market regulation.

Within the visit framework, the educational seminar was held on October 2, with participants from the Department for Pharmaceutical and Medical Industry Development of the Minpromtorg of Russia, representatives of the Inspectorate and the Educational center of FSI “SID and GP”, specialists from Roszdravnadzor. The seminar program included the following topics: PIC/S background information for the Applicant, common problem areas before they are evaluated for PIC/S participation, PIC/S GMP inspection approach, classification of GMP non-conformities, GMP requirements for contract manufacturing, international regulatory interaction.

Reference:

Robert Wayne Tribe/ Роберт Вейн Трайб. Employee of the Australian GMP Inspectorate (TGA) from 1971 to 2004. From 1980 to 2004 – headed the GMP inspectorate (24 years) and from 2000 to 2001 was the PIC/S Chairman. Advised 17 countries and regulators on the PIC/S entry. An experienced expert on membership in PIC/S; experience as a regulator of GMP and participation in PIC/S activities; Work experience with international organizations: Expert GMP Advisor to TGA (www.tga.gov.au); Expert GMP Advisor to APVMA (www.apvma.gov.au); Expert GMP, Advisor on PIC/S (www.picscheme.org); Эксперт GMP, советник ВОЗ (www.who.int); Regulatory Advisor to ISPE (International Society for Pharmaceutical Engineering) on regulatory affairs matters within the Asia/Pacific region (www.ispe.org).