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.
Our company performs voluntary on-site pharmaceutical audits both in Russian 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.
If you are willing to 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.
All our Experts-auditors possess practical experience of work at pharmaceutical productions and extensive experience in auditing of foreign 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.
Our Experts-auditors 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.
The similar method of training was applied for pharmaceutical inspectors training of national inspectorates of Russia, Belarus, Kazakhstan, Armenia and other countries.
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.
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.