Locations inspection manufacturers

drugs

Conducting GMP audits in order to
prepare for the upcoming inspection
by the national inspectorate... More

 

The geography of our audits covers

Russia and CIS countries

Western and Eastern Europe,
countries of Southeast Asia and
the Middle East, India, Japan

GMP inspection and audit

Performance of GMP audit

  • After performed audit you get a report on evaluation of your pharmaceutical production for compliance with GMP requirements. The Report will contain evaluation results as well as detailed indication of revealed non-conformities to GMP requirements, their classification (critical, major, minor) and reference to GMP paragraphs to which such non-conformity relates. Based on criticality of the revealed non-conformities it will be concluded whether or not your enterprise meets the GMP requirements.
  • You can commission our company to perform audits of manufacturers/distributors of API, auxiliary raw materials, printing and packaging materials for your production both in Russia and abroad as well as preparation of Report on their compliance with GMP requirements
  • Acting as Customer for activity transferred to another company (outsourcing), e.g. contract manufacturing, analytical testing, etc., you can commission us evaluation of Contractor for Contractor’s compliance with GMP requirements and Contractor’s ability to perform properly the obligations under outsourcing agreement.

 

 Performance of GDP audit

  • After performed audit you will get a report on evaluation of your enterprise engaged in medicines distribution for compliance with GDP requirements (GDP Rules) of the Eurasian Economic Union approved by decision of ECE Council No 80 dated 03.11.2016. The Report will contain evaluation results as well as detailed list of revealed nonconformities, their classification (critical, major, minor) and reference to the Rules’ paragraphs to which such nonconformity relates. Based on the criticality of the revealed nonconformities it will be concluded whether or not your enterprise meets the Rules’ requirements.

 

CAPA analysis

  • Support of CAPA elaboration performed by specialists of your enterprise upon the results of audit conducted by our company, by other audit companies or national inspectorate.
  • Documented expert evaluation of CAPA elaborated by your specialists upon the results of inspection performed by national inspectorate without visit of production site.
  • Audit of CAPA implementation with preparation of Report on the results of CAPA implementation evaluation with visit to production site.
  • Support at preparation of necessary additional materials for their submission to national inspectorate in order to explain and justify your position on the nonconformities revealed at inspection.

 

Application for GMP

  • Documentary expert evaluation of the set of documents elaborated by your specialists for submission to authorized federal executive institution of RF (Ministry of Industry and Trade of RF) to get GMP certificate of compliance of manufacturer (non-resident manufacturer) of medicinal products for human use with EAEU GMP requirements, its completeness and content sufficiency in accordance with the approved Administrative Regulations (order of the Ministry of Industry and Trade of RF as of September 04th 2020 under No 2945 "On approval of the Administrative Regulations of the Ministry of Industry and Trade of the Russian Federation for the provision of public services for issuing certificates of conformity of manufacturers of medicinal products for human use with the requirements of the rules of good manufacturing practice Eurasian Economic Union").
  • Formation and submission of the set of documents within requirements of Administrative Regulations (order of the Ministry of Industry and Trade of RF as of September 04th 2020 under No 2945 "On approval of the Administrative Regulations of the Ministry of Industry and Trade of the Russian Federation for the provision of public services for issuing certificates of conformity of manufacturers of medicinal products for human use with the requirements of the rules of good manufacturing practice Eurasian Economic Union") necessary for organization and performance of inspection of your medicinal products manufacture for compliance with EAEU GMP.

 

Consulting services

  • We will provide you with consulting service and professional assistance in implementation of GMP and GDP requirements
 
 

8-495-004-50-76

105064, Moscow, Nizhny Susalny lane, 5, p.19 room XI, room.2

info@gmp-project.ru

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"GMP-Project" - a company that specializes in assisting in the preparation of the inspection of manufacturers of medicinal products for compliance with the rules of good manufacturing practice, the activity of which is located outside the Russian Federation.