Validation and Maintenance of cGMP Methods
Validation of analytical methods
In this webinar, Christoph Jansen discusses the most relevant method validation questions with Bob McDowall.
This is the next chapter of our “Data Integrity” webinar tour, clear explanations of the topic will be given by the renowned expert. The most relevant aspects and requirements for method validation and maintenance will be explained. It is possible to overdo the process and run into a “death by compliance” situation, which should be avoided. We will explain some most common pitfalls. The “c” in “cGMP” indicates that the regulations and their interpretation need to be kept current and change over time and it is not a static document. Often, the dynamics of the regulations and guidance and the interpretation of them are underestimated by pharma companies.
Method validation is a hot topic at the moment: a new USP general chapter <1220> draft was published in September 2020, and update of ICH Q2(R1) and a new guidance on analytical procedure development [ICH Q14] will impact method development and validation are in process. All of which means that analytical procedures will be following an analytical procedure lifecycle management (APLM) over time and will include the most critical part that is currently out of scope – method development.
Development sets the scene for the validation by defining the design space, which is validated. Any change within the design space can be made as it is validated. Firmware upgrades and linking to respective requirements in USP and ICH will also be topics explored.