Review of scheduled, unscheduled, and foreign GMP inspections of pharmaceutical production facilities (June 2026)

This analytical review is based on official data obtained from the Register of GMP inspection results published by the Russian Ministry of Industry and Trade (as of June 19, 2026). The analysis covers three key data sets: scheduled inspections of Russian enterprises (PPS), unscheduled inspections of Russian enterprises (VPS), and foreign inspections.

1. Scheduled inspections of Russian manufacturers (PPS)

As part of scheduled inspections (PPS), the results of inspections of 96 Russian manufacturing sites were analyzed.

Statistics demonstrate the regulator’s extremely strict approach to the initial assessment of quality systems:

• Results of Part I: Only four sites (approximately 4.2%) were deemed fully compliant with GMP requirements immediately after the initial inspection. Only PRAXAIR SAMARA LLC, two manufacturing sites of Argon LLC, and EMC JSC achieved this result. The vast majority – 92 enterprises (95.8%) – received a “Non-compliant” status due to the identification of Critical, Major, and other non-compliances.
• Maximum number of violations: The anti-rating for the number of Major non-compliances included the Russian Anti-Plague Institute “Microbe” (33 Major violations), Kislorod Service Pharm LLC (32 violations), and ProMed LLC (29 Major and 3 Critical violations). The Armavir Biofactory Federal State Enterprise had the highest number of Critical violations (4 points).
• Results of Part II (after addressing the issues): Practice demonstrates the high effectiveness of companies’ implementation of corrective and preventive actions (CAPA). Based on the results of Part II, 42 manufacturing sites were awarded “Compliant” status, another 44 were assigned “Under correction” status, and only 10 facilities were ultimately deemed non-compliant with quality standards.

2. Unscheduled inspections of Russian manufacturers (VOS)

Unscheduled inspections (VOS) typically focus on specific quality indicators or large-scale changes in production, so their results are traditionally more stringent. A total of 24 such inspections were analyzed.

• None of the enterprises achieved full GMP compliance following the unscheduled visits.
• 16 inspections resulted in a categorical verdict of “Non-compliant.”
• In 8 cases, inspectors issued a decision on “Partial acceptance” (this category included, in particular, such sites as Velpharm LLC, the N.N. Blokhin National Medical Research Center of Oncology, the St. Petersburg Research Institute of Vaccines and Serums of the Federal Medical and Biological Agency of Russia, and PSK Pharma LLC).

3. Foreign GMP inspections

The dataset for overseas sites includes 134 inspections conducted and shows a significantly more positive picture of manufacurers’ readiness.

• Geography of inspections: India, France, and the United States (17 sites each) led the way in terms of the number of sites inspected in the 2026 period, closely followed by Italy (16 sites) and Germany (14 sites). Significant numbers of inspections were also conducted in Switzerland (7) and Spain (6).
• Results of Part I: The initial readiness level of foreign sites was several times higher than that of Russian ones. Following the results of Part I, 65 foreign enterprises (48.5%) were deemed compliant with GMP regulations, while 69 were assigned the status “Non-compliant.”
• Results of Part II: The final assessment revealed an excellent level of non-compliance resolution. Ninety-two foreign facilities fully confirmed their compliance, and 40 sites are in the “Under correction” status. Only two Indian manufacturing sites received final non-compliance: Quality Pharmaceuticals Ltd. (with one Critical and 10 Major violations) and Cadila Pharmaceuticals Limited (with two Critical and 15 Major findings).
• Maximum number of violations: The worst results in terms of the number of identified Major violations among foreign companies were shown by the Bulgarian site Vetprom AD (18 Major and 1 Critical non-compliance) and the already mentioned Indian Cadila Pharmaceuticals Limited.

Conclusions and insights:

• • A huge gap in initial compliance: There is a huge gap between Russian and foreign manufacturers based on the results of initial inspector assessments. While almost 50% of foreign sites pass the inspection without Major violations (Part I), among Russian scheduled inspections, this figure falls below 5%. This demonstrates both the higher level of maturity of quality systems in the global market and the extremely strict approach Russian inspectors take with domestic manufacturers.
  • Effectiveness of the corrective action mechanism: Despite strict initial controls, the corrective action system proves its effectiveness. About 44% of Russian enterprises and almost 69% of foreign enterprises ultimately correct errors and demonstrate their effectiveness in Part II.
  • Diversification and stability of imports: Active inspections of manufacturing facilities in the US, France, Germany, and Italy (with high rates of final approval) underscore that regulatory mechanisms for monitoring the entry of Western drugs into the Russian market continue to function actively, in parallel with widespread inspections of facilities in the Asian region (India, China).