Dr Joachim Ermer, Ermer Quality Consulting, Germany
This Live Online Training provides regulatory requirements and recommendations with respect to the transfer of analytical procedures, e.g. from USP, WHO, and ISPE. Transfer can be regarded as the ultimate robustness check of the analytical procedure. Aspects neglected or missed during method development will often become evident. Therefore, a meticulous planning and a prudent management of issues during the transfer are vital. A thorough Quality-by-Design method development or otherwise retrieved knowledge on the performance of the analytical procedure will facilitate an efficient planning of the transfer as well as increase the probability of success.
The transfer of analytical procedures is a frequent activity during the lifecycle of a drug substance or drug product. Thus, it is regularly in the focus of audits and inspections. According to the EU GMP guide part 1, chapter 6, Quality Control, and US 21 CFR 211.194, QC laboratories which did not perform the original validation should verify the appropriateness of the testing method. The EU GMP guide (6.38 – 6.40) requires a protocol for this analytical transfer. The General Information Chapter of USP <1224> „Transfer of analytical procedures“ provides some detailed discussion of the process, including various transfer strategies such as comparative testing, co-validation, re-validation, and waiver.
This Training is aimed at executives and employees from Quality Control, Quality Assurance, and Production who want to gain a better understanding of the GMP requirements, as well as an efficient planning, execution, and evaluation of a successful method transfer.
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