Tag: GMP Inspectorate

Russian Pharma Supports Unified EAEU GMP Inspectorate

Association of Pharmaceutical Manufacturers of the Eurasian Economic Union with the support of the Ministry of Industry and Trade of Russia, the Eurasian Economic Commission held a specialized confere...

Russian and Japanese GMP-Inspectorates to Share its Experience

Representatives of the Russian GMP inspectorate will conduct a series of meetings with Japanese colleagues as part of professional cooperation on conducting GMP inspection inspections, the External Co...

How to Read Indefinite Legal Terms of GMP Regulators

The GMP regulations are "bombarded" with indefinite legal terms. Things should be appropriate, regularly repeated, or sufficient. To be precise, this can also be found as a requirement in the EU GMP G...

The Russian and the Chinese GMP Inspectorates discussed the prospects for cooperation

In Beijing, a meeting between the Russian state GMP inspectorate and the Chinese regulator CFDI (Center for Food and Drug Inspection) was held. As a follow-up to the meeting, the inspectorate has star...

Spanish AEMPS and Russian “SID & GP”Agreed on Cooperation

In Moscow, an agreement was signed between the State Institute of Drugs and Good Practices (SID & GP) and the Spanish Agency of Medicines and Medical Devices (AEMPS). Under the agreement, the two ...

Meeting of Russian GMP Inspectorate and EDQM

A meeting with the Deputy Head of the Russian State GMP Inspectorate, the Director of FSI «SID & GP» Mr. Vladislav Shestakov was organized at the headquarters of the European Directorate for the Q...

Mutual Recognition of GMP Certificates in EAEU

In Sochi, within the «Healthy Life. On the Way to Target 80+» Forum, a session under the topic «The system of universal health coverage as a key to achieving the national target» was held. How much...

Results of Inspection of Veterinary Products for the GMP Compliance

Inspection activities aimed at confirming the compliance of a manufacturer of veterinary medicinal products with the requirements of Good Manufacturing Practice (GMP) are carried out by the Federal Se...

SID & GP summarized the work carried out over the past year

The results of the work by the GMP-inspectorate became the main topic of the meeting with representatives of the top Russian mass media held by the Director of the FSI 'SID&GP'.

Five EU countries were included into the EU-US mutual recognition agreement

The US Food and Drug Administration confirmed the capability of five additional EU Member States to carry out good GMP inspections at a level equivalent to the United States.

EMA/EDQM inspection found 24 GMP violations at heparin manufacturing in China

pharmaceutical manufacturing
The inspection identified 24 GMP deficiencies and seven were categorized as major. The extraction of substance, physical processing and packaging and biological testing were found to be noncompliant.

‘RegLek-2018’ conference participants discussed issues in drug evaluation

On 19th November the scientific-practical conference 'RegLek-2018', was held in Moscow. Participants of the event discussed the modern approaches to drugs expert evaluation.

FSI ‘SID&GP’ starts the community of experts ‘PharmaPharm’

The community of experts has been started at FSI "SID & GP" of Minpromtorg of Russia, which provides invaluable expert support throughout the whole period of web-site development.

SID&GP inspectors participated in training GMP inspection

On October 8 and 9, inspectors of the SID&GP together with their peers from Armenia and Kazakhstan took part in a mock GMP inspection at the Gideon Richter Chemical Plant in Budapest (Hungary).

SID&GP presented the inspection overview of foreign pharma manufacturers

Mr. Vladislav Shestakov presented a review of the results of inspections of foreign pharmaceutical manufacturers at the PharmMedCirculation 2018 conference.

SID&GP participated in PIC/S Committee meeting

Tatyana Nikolko, Deputy Head of the Administration for Pharmaceutical Products Inspection and Evaluation took the floor with a presentation on the Russian GMP Inspectorate.