The Board of the Eurasian Economic Commission (EEC) has approved a draft amendment to the GMP Rules, revising the requirements for the manufacture of sterile medicinal products. The document introduces stricter monitoring protocols for cleanrooms and personnel operations.
The Board of the Eurasian Economic Commission (EEC) has developed a draft decision on amendments to the Good Manufacturing Practice (GMP) Rules of the Eurasian Economic Union (EAEU) regarding requirements for the production of sterile medicinal products. Order No. 49 dated April 14, 2026, has been published on the Union's legal portal.
A key requirement of the new edition is the implementation of a "Contamination Control Strategy" (CCS) at each manufacturing site. The CCS is a single, documented set of measures covering facility design, equipment, engineering systems, personnel, process validation, cleaning, disinfection, and monitoring.
Particular attention in the document is given to operator qualification. Personnel working in Grade A and B areas must annually confirm their proficiency in the correct donning of sterile garments, with both visual and microbiological assessment. Unsupervised access to these areas is granted only after successfully completing the gowning procedure and participating in a successful Aseptic Process Simulation (APS). APS must be conducted at least twice a year for each production line, each aseptic process, and each work shift.
The document also introduces a requirement to verify the integrity of sterilizing filters prior to use following sterilization. However, it acknowledges that in certain cases (e.g., filtration of extremely small volumes), such testing may be technically unfeasible. For these scenarios, an alternative approach is permitted, subject to thorough risk assessment and enhanced controls.
The approved draft will be submitted to the EEC Council for consideration.
Source: Pharmaceutical Herald
