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Typical non-conformities of foreign pharmaceutical sites to chapters of GMP rules

A conference with international participation “Unity of pharmaceutical and clinical development: GxP standards in the drug life cycle” was held in Moscow, where the main questions were addressed to representatives of the Russian state GMP inspectorate.

What is the procedure for inspecting foreign manufacturers for compliance with the rules of good manufacturing practice, which inconsistencies are most often found at sites, the implications for the manufacturer who did not eliminate the inspectorate’s comments - these are just a small list of issues that concern the pharmaceutical community and are regularly asked to the inspectorate. The GxP standards conference was no exception.

According to the FBU “GILS and NP” inspectorate, in 2018, 3 503 inconsistencies were identified, of which 135 (5%) were classified as critical, 1 438 - (46%) as significant, and 1 531 (49%) - as insignificant.

If we analyze these data through the prism of inconsistencies to specific chapters of the GMP rules, enshrined in the Order of the Ministry of Industry and Trade of Russia No. 916 “Rules for organizing the production and quality control of medicines”, it becomes clear that the greatest number of inconsistencies affecting the quality of medicines and, as a result, life and patient health concerns Appendix 1 and Chapter 1:

• Evaluation of the quality of the finished product (for non-sterile solid dosage forms) and obtaining permission to release is carried out on the basis of quality control of bulk goods. Finished products are not controlled in final packaging (Chapter 1, p.5,13).
• Release of drugs into the circulation on the territory of the Russian Federation without a full range of tests specified in the regulatory documentation for the drug (Chapter 1, p.5.13).
• Conducted tests for the release of the finished product into circulation do not comply with the control methods specified in the regulatory documentation (Chapter 1, p.5,13).
• The series of the medicinal product, produced with significant changes and / or significant deviations in the production process, are not laid for subsequent stability studies (Chapter 6. p. 233).
• Sampling of raw materials used for the production of sterile drugs is carried out in the unclassified zone (Appendix 1, p.3, 4, 11).
• Organization of the production process does not meet the requirements to the production of sterile drugs (Appendix 1, p. 38, 81).
• With aseptic filling, re-filtration is not carried out through an additional sterilizing filter that delays microorganisms (Appendix 1, paragraph 18).

More details about the features and best practices of inspection of pharmaceutical production for compliance with GMP standards, harmonization of inspection rules within the single market of the EAEU, approaches to the formation of corrective measures based on the inconsistencies identified during the inspection, experts from the Russian state GMP inspectorate and representatives of foreign regulators will speak at two days a GMP Inspection master class at a GMP conference to be held September 23-25 in Kaliningrad.

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