MINISTRY OF INDUSTRY AND TRADE OF THE RUSSIAN FEDERATION
CONCLUSION on the compliance of the manufacturer (foreign manufacturer) of medicinal products for human use with the requirements of the Good Manufacturing Practice
No. GMP-####
Part 1
The Ministry of Industry and Trade of the Russian Federation confirms that Limited Liability Company (some name here) (full and abbreviated name (if any) of the manufacturer (foreign manufacturer) of medicines for human use) located at: Address of the pharma company we performed the translation for
carrying out the production of medicines for human use at: again, their address here
passed an inspection as part of licensing control for compliance with licensing requirements in the implementation of activities for the manufacture of medicines in accordance with the license dated some date here No. ## pursuant to the legislation of the Russian Federation or passed an inspection in terms of registration certificate(s) indicating manufacturers located outside the Russian Federation, in accordance with the requirements of the Rules of Good Manufacturing Practice, approved by order of the Ministry of Industry and Trade of the Russian Federation dated ### No. ##.
GMP-##
Based on the information obtained during the inspection of this manufacturer, the last of which was carried out on ##, it follows that it complies with the requirements of the Rules of Good Manufacturing Practice approved by order of the Ministry of Industry and Trade of Russia dated ## No. ##.
This conclusion reflects the compliance status of the manufacturing site of the manufacturer (foreign manufacturer) of medicinal products for human use at the time of the above inspection and should not be perceived as a document indicating the compliance status in the event that more than 3 (three) years have passed since the date of this inspection.
The Conclusion is valid when all of its pages are provided (both part 1 and part 2).
The authenticity of this conclusion is verified in the register of conclusions on the compliance of manufacturers of medicines for human use with the requirements of the Rules of the Good Manufacturing Practice, posted on the official website http://www.minpromtorg.gov.ru, http://www.минпромторг.рф. In the absence of this conclusion in the register of conclusions on the compliance of manufacturers of medicines for human use with the requirements of the Rules of Good Manufacturing Practice, please inform the Ministry of Industry and Trade of Russia.
This conclusion is valid for 3 years from the date of the end of the inspection.
First Deputy Minister /Signature/ S.A. Tsyb
/Seal/: Ministry of Industry and Trade of the Russian Federation * MINPROMTORG OF RUSSIA * OGRN #####
Some date here
Date of issue of the conclusion
MINISTRY OF INDUSTRY AND TRADE OF THE RUSSIAN FEDERATION
GMP-#####
Part 2
Manufacture and quality control
I. MANUFACTURING OPERATIONS - MEDICINAL PRODUCT
1. Sterile products
□ 1. Products prepared aseptically (processing operations for the following dosage forms):
□ large volume liquid dosage forms
□ small volume liquid dosage forms
□ variance
□ lyophilisates
□ solid dosage forms and implants
□ soft dosage forms
□ other products
□ 2. Products undergoing terminal sterilization (processing operations for the following dosage forms):
□ large volume liquid dosage forms
□ small volume liquid dosage forms
□ solid dosage forms and implants
□ soft dosage forms
□ other products, dosage forms
□ 3. Release quality control:
2. Non-sterile products
1. Non-sterile products (processing operations for the following dosage forms):
□ hard shell capsules
□ soft capsules
□ chewable dosage forms
□ impregnated dosage forms
□ liquid dosage forms for external use
□ liquid dosage forms for internal use
□ medical gases
□ other solid dosage forms
□ drugs under pressure
□ generators of radionuclides
□ soft dosage forms
□ candles (suppositories)
□ tablets
□ transdermal patches
GMP-####
□ devices for intra-ruminal (intra-cicatricial) injection
other products, dosage forms:
pharmaceutical substances obtained by chemical synthesis methods; pharmaceutical substances obtained by methods of extraction from chemical raw materials
□ 2. Release quality control:
3. Biological medicinal products
□ 1. Biological medicinal products:
□ blood products
□ immunological products
□ products based on somatic cells
□ gene therapy products
□ tissue engineering products
□ biotechnological products
□ products extracted from animal sources or human organs (tissues)
□ other products
□ 2. Release quality control (list of product types):
□ blood products
□ immunological products
□ products based on somatic cells
□ gene therapy products
□ tissue engineering products
□ biotechnological products
□ products extracted from animal sources or human organs (tissues)
□ other products
4. Other products or manufacturing activities 1. Manufacture:
□ plant products
□ homeopathic products