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 transfer process.
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.
Target Group
The webinar 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 succesful method transfer.
Technical Requirements
For our webinars, we use Cisco WebEx, one of the leading suppliers of online meetings.
At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and email address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
Programme
The webinar provides regulatory requrements and recommendations with respect to the transfer of analytical procedures, e.g. from WHO and ISPE.
The following aspects will be covered:
Regulatory requirements and recommendations
Analytical transfer as part of the lifecycle management
Management of the transfer process (transfer team, documentation, strategy, protocol, training, report)
Design of experimental studies
Transfer acceptance criteria (accuracy and precision)
Evaluation of results (simple and statistical comparison)
Root causes of issues during transfer
Management of deviations, suspect and out-of-specification results
Testimonials