On July 1, 2026, the Council of the Eurasian Economic Commission published Decision No. 67 (adopted May 20, 2026), which introduces extensive changes to the EAEU GMP Rules. The updated Appendix 1 “Requirements for the Production of Sterile Medicinal Products” is harmonized with international standards (a similar version of the EU GMP has been in effect since August 2024), expanding the export potential of Union manufacturers.
Key innovations
– A contamination control strategy (CCS) is a mandatory, unified, documented set of measures covering design, equipment, personnel, validation, cleaning, and monitoring of all critical points. This represents a transition from disparate procedures to a holistic risk management system.
– Quality Risk Management (QRM) – implementation of QRM principles at all stages of the product lifecycle. Any alternative solutions require scientific justification and risk assessment.
– Barrier technologies – requirements for isolators and RABS systems have been tightened: standards for gloves and biodecontamination have been detailed , and conditions for open and closed systems have been separated.
– Environmental monitoring – continuous particle monitoring (≥ 0.5 and ≥ 5 µm) at all critical stages is implemented in Class A zones; monitoring of viable particles during equipment setup and identification of microorganisms to the species level are mandatory in Zones A and B.
– Personnel qualifications – aseptic zone operators undergo annual recertification on the dressing procedure; admission without supervision is only after successful simulation of the aseptic process (APS, at least twice a year per line and shift).
– Sterilizing filtration – a pre-use post-sterilization filter integrity test (PUPSIT) is being introduced, with possible exceptions subject to a validated risk assessment.
– FFS and BFS technologies – expanded requirements for critical process parameters, material control and monitoring, including rotary units.
Introduction deadlines
The transition to new standards is being carried out in stages:
– 180 days after publication, the main requirements come into force;
– after 3 years (1095 days) – requirements requiring modernization of production facilities (PUPSIT, material transfer, BFS monitoring, integrity of lyophilizers , assessment of leachables for single-use systems).
