USP Guidance For Both Sides Of A Method Technology Transfer Milestone
By Louise Garone, Consulting Principal Analytical Scientist, Enterprise System Partners
The thesis of this white paper is that adopting all updates effective in three general chapters of the US Pharmacopoeia (the most recent dated December 2013) will enable projects to progress more efficiently across what has been called the Critical Path1 of pharmaceutical development. The analytical development, quality control, and quality assurance functions in technology transfer-originating and technology transfer-receiving companies are directly involved with the processes standardized by those chapters. Working together these functions in an originator company constitute what we refer to here as the “Sending Unit.” The mirror-imaged functions found in a technology transfer-receiving company constitute the “Receiving Unit.”
The relevant USP General Chapters are <1224> Transfer of Analytical Procedures2, <1225> Validation of Compendial Procedures3, and <1226> Verification of Compendial Procedures4. This white paper introduces the method technical transfer campaign as an operational milestone because it is the means by which a manufacturing facility, or more specifically the “Receiving Unit” in that facility, is recognized as qualified to perform the test methods required, to ensure quality of a particular product. Other milestones, such as individuals’ educations, company-specific training, quality system certification, and company-wide adoption of recognized industry best practices5 fall outside the scope of this paper and are assumed to be already in place.
Method technical transfer is a documented process to ensure the laboratory component of the receiving unit has the procedural knowledge and ability to perform the transferred test method as intended. Method technical transfer qualifies the receiving unit laboratory to use an analytical procedure that originated in another laboratory, part of the sending unit. The transfer of analytical procedures for testing raw materials and for in-process and release testing of a biopharmaceutical can be very challenging if poorly organized and documented. Moreover, failed or ineffective method transfer can result in the loss of time and resources. Therefore, it is worthwhile to build an efficient framework for analytical test method technical transfer.