Transfer of Microbiological Methods for the Pharmaceuticals Quality Control

INTRODUCTION. The transfer of microbiological methods is an important aspect of analytical methods transfer as part of technology transfer between production sites of the same or different pharmaceutical companies, as well as to contract laboratories. The regulatory and organizational aspects of analytical method transfer are clearly defined and described in the scientific literature, while the transfer of microbiological methods, when not specifically identified as a separate area, often presents a number of challenges, for instance lack of specialized premises and qualified staff, permission to work with pathogenic microorganisms, etc.

AIM. Developing an algorithm for the transfer of microbiological methods for drug quality analysis, taking into account the specifics of individual transfer procedure steps.

DISCUSSION. Method transfer is a mutually beneficial process for both the receiving and the transferring parties. When preparing for the transfer of a microbiological method, the parties analyze and assess quality risks across a number of criteria (lab equipment, staff, QMS documentation, etc.), consider the possibility of combining technologies, analyze discrepancies, and make any necessary changes. A transfer plan is then developed; it includes methodological specifications for validation testing, parameters, and acceptance criteria. The microbiological method transfer algorithm requires certified facilities, a license to work with microorganisms of pathogenicity groups 3–4, and trained staff specialized in microbiology and microbial biosafety. The transferring and receiving parties can jointly implement staff training programs. Official pharmacopoeial methods do not require transfer. Using alternative microbiological methods extensive comparative validation studies are required.

CONCLUSIONS. The transfer of microbiological methods is the most critical part of the transfer process at a pharmaceutical company, which is currently based on OFS.1.1.0030 GF RF, OFS 2.3.16.0 FEAEU, and EEC Guideline No. 11 dated June 8, 2021. Reasonable amendments to the transfer procedure may be made regarding the functioning of a specific laboratory, including microbiological monitoring, cleaning validation, etc.

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