GMP audits of manufacturing sites

The DOCLINX team provides services for preparing manufacturing sites to obtain a GMP certificate in accordance with the rules of the Eurasian Economic Union (Union).

What is the purpose of a GMP certificate?

Good Manufacturing Practice (GMP) is a set of rules establishing requirements for the organization of production and quality control of medicinal products for medical use.

The production of medicinal products for citizens of the EAEU member states must comply with the Union's Good Manufacturing Practice Rules. The manufacturer is obliged to produce medicinal products in a way that ensures their conformity with their intended use, as well as the requirements of the registration dossier and/or clinical trial protocol. At the same time, it is necessary to minimize risks to patients associated with the safety, quality, and efficacy of medicinal products.

The document confirming compliance with the requirements of the Union's Good Manufacturing Practice (GMP certificate) is a mandatory element of the registration dossier for a medicinal product. It is necessary for new registration, re-registration, or bringing into compliance with the Union's requirements.

What services does DOCLINX provide?

• Preparation of the site for inspection with a preliminary audit
• Preparation of the site for inspection without audit: providing a checklist, a list of typical observations, and conducting a teleconference with the site (question and answer session)
• Preparation of a response to the request from the authorized body and/or inspectors before the inspection
• Accompanying the inspectorate during the visit to the manufacturing site
• Assistance in developing a Corrective and Preventive Action (CAPA) plan based on the inspection results

Personalized commercial offerl

To receive a personalized commercial offer corresponding to the specifics of your situation, follow the appropriate link and answer a few questions:

• GMP audit/inspection of a medicinal product manufacturer
• GMP audit/inspection of an API manufacturer

Regulatory acts

• Decision of the EEC Council dated 03.11.2016 No. 77 "On approval of the Rules of Good Manufacturing Practice of the Eurasian Economic Union"
• Decision of the EEC Council dated 03.11.2016 No. 82 "On approval of the General Requirements for the Quality System of Pharmaceutical Inspectorates of the Member States of the Eurasian Economic Union"
• Decision of the EEC Council dated 03.11.2016 No. 83 "On approval of the rules for conducting pharmaceutical inspections"
• Order of the Ministry of Industry and Trade of the Russian Federation dated 04.09.2020 No. 2945 "On approval of the administrative regulations of the Ministry of Industry and Trade of the Russian Federation for the provision of state services for issuing certificates of conformity of manufacturers of medicinal products for medical use to the requirements of the Good Manufacturing Practice rules of the Eurasian Economic Union"