Published: 4 March 2009
Consultations
Outcome of Consultation on the Draft Guideline for the Transfer of Analytical Procedures
4 March 2009
Eleven submitters, including regulatory consultants, pharmaceutical companies and industry associations responded to the request for feedback on the May 2008 draft "guideline for the transfer of analytical procedures".
The most common themes in the responses were:
- requests for clarification about validation (including analytical procedure transfer) requirements for pharmacopoeial methods
- comments on the role GMP plays with respect to the transfer of analytical methods
- requests that the technical transfer requirements be sufficiently flexible to allow the use of company transfer protocols.
Following consideration of the feedback from submitters, and information from other regulatory agencies, Medsafe has revised the guideline. The main changes are:
- drawing the distinction between validation requirements for pharmacopoeial methods and non-pharmacopoeial methods
- drawing the distinction between analytical procedure transfer requirements for pharmacopoeial methods and non-pharmacopoeial methods
- providing increased flexibility in the technical aspects of analytical procedure transfer to accommodate different technical solutions, which have been developed by individual companies with documented approaches
- clarifying Medsafe's data expectations with regard to the submission of a New Medicine Application (NMA) or Changed Medicine Notification (CMN)
- clarifying that this guidance applies to non-prescription and prescription medicines.
Medsafe acknowledges that validation of the transfer of analytical procedures is an aspect of GMP. Medsafe's experiences with some manufacturing sites confirms that verification of successful analytical transfer is necessary during pre-market registration. For example, it is not uncommon to receive comparative analysis on blank samples. Obviously, such an oversight casts into doubt the competency of the testing site, despite the existence of current GMP certification. Equally, the unavailability of transfer reports or transfer data from sites testing and releasing product is inconsistent with GMP.
The final guidance document on the transfer of analytical methods is located within the revised New Zealand Regulatory guidelines Volume 1 6th Edition, Part D, Section 9.
Consequential changes have been made to the Prescription Medicines Checklist.
