USP method transfer underwent a change when the US Pharmacopoeia published the final version of its informational chapter 1224, which deals with the transfer of analytical procedures mentioned in the document entitled USP 35-NF 30. This became official in May 2012.
How is the new document different?
The US Pharmacopoeia had earlier issued the 1224 stimuli document in response to comments it received from users and professionals globally. The new version of chapter 1224, which is the general article, is different in one fundamental way in that it makes risk based assessment the criterion for the nature and scope of transfer activities. So, this new version of USP method transfer is different in one small, but very significant way.
What are the major elements of the new USP method transfer version?
The May 2012 USP method transfer recommends many new elements. Some of these are listed below:
- The laboratories have to prepare a detailed analytical procedure with instructions that are sufficient and explicit enough to allow a trained analyst to perform it painlessly
- All questions regarding the transfer process have to be clarified at a pre-transfer meeting between the transferring and the receiving units
- The written analytical procedure and development validation reports have to be transferred to the receiving unit from the transferring unit
- The transferring unit has to train staff of the receiving unit
- A dry run of the procedure has to be conducted at the receiving unit
- Issues that may need resolution have to be identified before the signing of the transfer protocol
- All the required identification, calibration and qualification needed of respective analytical instruments have to be carried out
- Compliance with relevant regulations of the laboratory systems of the two units has to be confirmed
What are the implications of failure to meet acceptance criteria?
According to the USP method transfer; failure of the sending or receiving fails to meet acceptance criteria qualifies as a serious, but not fatal error. It does not get classified under Out-of-Specification (OOS) result whose desired action is investigation into the root of the OOS. However, this requires discussion and justification of any deviation. Either of the laboratories –the sending or receiving –should investigate the reason for which the predicted acceptance criteria were not reached, and should take corrective measures. This process makes USP method transfer complete. The transfer can take place only when the acceptance criteria are met, the failure of which prevents the transfer from taking place.
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