GMP Inspection Services

Starting in 2016, for new medicinal product (MP) registrations in Russia, pharmaceutical companies are required to furnish evidence of Good Manufacturing Practice compliance, as mandated by the Resolution of the Government of the Russian Federation No. 1314 dated 03.12.2015. This includes submitting an equivalent certificate or license from the appropriate authority in the country of origin for products manufactured outside of Russia. Additionally, from 2017, adherence to Good Manufacturing Practice has become mandatory for both renewal of registrations and amendments to existing registration dossiers.

The Ministry of Industry and Trade of Russia (Minpromtorg) serves as the executive authority overseeing inspection processes. These inspections are conducted by the Federal Budgetary Institution’s State Institute of Drugs and Good Practices (FBI SID and GP) under Minpromtorg.

The enactment of Law No. 140-FZ “On Circulation of Medicines” on 04.06.2018 has streamlined the registration process for MPs manufactured internationally, as well as the procedure for updating registration documents. Nonetheless, in cases where foreign GMP compliance documentation is not recognized by Minpromtorg, the Russian Federation reserves the right to refuse state registration, re-registration, or any modifications to the registration dossier.

Raifarm specializes in providing comprehensive, expert assistance to ensure our clients are fully prepared for the Russian state inspection of medical products manufactured abroad. Our proficiency in this domain is grounded in a deep understanding of the regulatory landscape and a commitment to ensuring successful compliance for our clients.

Raifarm’s  services include:

• Expert Consultation for Foreign Manufacturer Inspections: We offer detailed consultations to assist in preparing and conducting inspections of foreign manufacturers, providing insights into the current inspection procedures.
• Collaboration with Manufacturers for Documentation Preparation: Working closely with manufacturers, we facilitate the preparation of essential documents for submission to the Ministry of Industry and Trade of Russia (Minpromtorg).
• Assistance with Corrective Action Plans: Our team provides guidance in preparing responses to findings from previous inspections, including developing and implementing Corrective and Preventive Actions (CAPAs) if required.
• Effective Communication with Regulatory Authorities: We handle communication with authorities regarding requests for additional materials and manage inspection follow-ups, coordinating with the manufacturer for scheduled inspections by the Federal Service for Surveillance in Healthcare (FSBI SID and GP).
• Logistics Support for Russian Inspections: Raifarm aids in resolving logistical or other issues as part of the inspection preparation process in Russia.
• Facilitation of Site Inspection Processes: We assist in fostering communication between manufacturing site staff and inspectors and, if needed, accompany inspectors during on-site evaluations.
• Preparation of Additional Inspection Materials: Collaborating with the manufacturer, we help in preparing any additional materials required for compiling the inspection report, negotiating the draft Good Manufacturing Practice (GMP) conclusion, and confirming its receipt.

Moreover, Raifarm specializes in conducting preliminary audits at foreign manufacturing sites in preparation for subsequent inspections, in line with the Order of the Minpromtorg of Russia No. 916 dated 14.06.2013, which approves Good Manufacturing Practice rules. We provide comprehensive reports identifying potential site issues and non-compliances with GMP standards, along with tailored recommendations for all necessary corrective actions. This thorough approach ensures that manufacturing sites are well-prepared to meet the stringent regulatory standards set forth by the Russian authorities.

Full Price Details

¹ Tailored Service Fee Structure: The service fee at Raifarm is variable and is determined based on the specificities of each case. A definitive fee range is established and agreed upon once a client accepts Raifarm’s tailored proposal for their unique requirements.

² Exclusions from the Service Fee: It is important to note that the service fee does not cover certain expenses. These include the costs for documentation translations, fees charged by the Federal Budget Organization “State Institute of Drugs,” and any necessary travel expenses.

³ Client Documentation and Sample Provision Timelines: The projected timeline for our services is contingent on the client’s prompt provision of all necessary documentation. Additionally, if relevant, this includes the supply of samples for pharmaceutical examination (for drugs) or testing (for medical devices), which is crucial for maintaining the scheduled timeline.

⁴ Inspection Scheduling and Manufacturing Site Consent: The estimated service period also depends on the manufacturing site’s agreement to undergo inspection on the dates suggested by the inspectors. This mutual understanding is key to adhering to the proposed schedule.