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 „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.
To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily display.
Timing and Duration:
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.
In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.
Training Course Documentation and Certificate:
The presentations will be made available as PDF files via download shortly before the online training course. After the event, you will automatically receive your certificate of participation.
Regulatory Requirements and Expectations
- Guidelines for transfer of analytical procedures
- Analytical transfer as part of the lifecycle management
- Management of deviations, suspect and out-of-specification results
Management of the Transfer Process
- Transfer team
- Transfer strategy
- Protocol and report, documentation
- Root causes of issues during transfer
Rational and Efficient Design of Transfer Studies
- Evaluation of results (simple and statistical comparison)
- Risk-based design of effort
- Acceptance criteria (accuracy and precision)
- Capability-based (empirical, from validation, from monitoring)
- Requirement-based (statistical derivation from specification limits, acceptable OOS rate)
- Design of experimental studies (required number of series and determinations, dependent on acceptance limits and evaluation)
- Based on knowledge and data from continuous monitoring in the sending unit
- Initial transfer study by receiving unit only
- “Lean” design, risk limitation for larger Errors/differences
- Post-transfer control by means of the monitoring program
- Chance to identify and evaluate small differences
Duration of the Recording: Appr. 2,5 h
Recording from 13 April 2021