Verification of Compendial Methods According to the Revised USP Chapter - Webinar By ComplianceOnli (Laboratory Complianc)
Venue: Online Event
|Event Date/Time: Jul 11, 2012||End Date/Time: Jul 11, 2012|
Compendial methods such as USP and EP standards are validated by the organizations that have developed and published the method. The FDA requires users of such methods to demonstrate the user's competence to successfully run the method. For example, 21 CFR 211.194 (a) states: The suitability of all testing methods used shall be verified under actual conditions of use. However, the FDA does not give any further guidance on what, when and how. And the first revision of USP <1226> did not have specific recommendations. But FDA inspectors go out and write 483's and warning letters related to <1226>. Now USP has announced to come out with a new revision using the risk based approach for the type and extend of testing.
- What are FDA and international requirements for compendial methods?
- What and how much should be tested?
- How to use the risk based approach?
- Is system suitability testing enough?
- Do all compendial routine methods require verification?
- When could just system suitability testing be enough?