Locations inspection manufacturers

drugs

In compliance with the rules
of good manufacturing practice,
activity which is beyond
outside the Russian Federation.

 

The geography of our audits covers

Russia and CIS countries

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

About

Activity of GMP-Project Company


GMP-Project LLC is a company engaged in services related to performance of GMP audits to prepare pharmaceutical manufacturers for inspection from the part of National Inspectorate for compliance with GMP requirements.

Voluntary audit


Our company performs voluntary on-site pharmaceutical audits both in Russia and abroad for compliance with GMP requirements approved by order of Russian Ministry of Industry and trade No 916 dated June 14th 2013 registered in Russian Ministry of Justice on September 10th 2013 under No 29938 as well as GMP rules of Eurasian Economic Union approved by Decision of the Council of Eurasian Economic Commission as of 03.11.2016 under No 77.

Why perform a voluntary audit?


If you are willing to do a proper preparation to the state inspection and receive reliable information on degree of compliance of your company to GMP requirements our experts can perform a voluntary audit of your Enterprise and provide a report based on the results of the on-site audit with indication of revealed discrepancies, level of their criticality with references to the chapters and items of GMP Rules.

Our Experts-auditors


  • Possess practical experience of work at pharmaceutical productions and extensive experience in auditing of foreign and Russian manufacturers.
  • Have necessary knowledge, completed professional retraining and have Diplomas corresponding to the level of Russian Inspectors that give them the right to conduct professional activity in the sphere of GMP inspections and pharmaceutical audits for compliance with GMP requirements.
  • Completed special training course and have international certificates issued by the only European center conducting trainings for pharmaceutical inspectors – Danish College of Pharmaceutical Practice in Denmark that closely works with WHO on medicines policy and development of pharmaceutical practice.
  • Completed the method of training that is similar to that applied for pharmaceutical inspectors training of national inspectorates of Russia, Belarus, Kazakhstan, Armenia and other countries.

Harmonized standards of voluntary audit performance


Our company’s application of unified approach to auditors training used by national inspectorates of Russia and other countries ensures harmonization of voluntary pharmaceutical productions audits performed by our experts with approaches and inspection standards used by authorized national institutions.

Performance of voluntary GDP audits


Along with specialization related to performance of GMP audits our company conducts audits of enterprises engaged in medicines distribution for compliance with GDP requirements (GDP audits). Specialists of our company possess professional education and diplomas confirming their high professional skills in this field.

 
 

8-495-004-50-76

105064, Moscow, 5 Nizhny Susalny lane, build 19, area 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.