‘Design Validation Protocol and Acceptance Criteria for Chromatographic Methods’ webinar
The Velesco team recently attended a validation webinar from the comforts of our conference room here at the MLSIC facility. The training titled ‘Design Validation Protocol and Acceptance Criteria for Chromatographic Methods’ was presented by Kim Huynh-Ba of Phamalytik. This webinar caught our attention as we’re always keen to keep up our knowledge on regulatory requirements and analytical method validation.
The webinar went into detail on the following topics:
– Validation parameters for HPLC analyses
– Regulatory requirements for method validations
– Specificity through forced degradation activities
– Stability Indicating Methods
In this webinar, an overview of the drug development process was presented followed by a detailed discussion of various validation parameters which included specific references to regulatory requirements, international GMP requirements and ICH guidelines. There was a strong focus on demonstrating specificity and ensuring that methods were stability-indicating. The webinar also explored in detail typical forced degradation experimental design and evaluation of method specificity.
Common deficiencies that have led to FDA warning letters were also discussed during this webinar. Some of these included: specificity not being determined during method validation or being required as part of the analytical procedure; unidentified HPLC peaks found during stability testing that were not identified or evaluated; and various modifications being used for product stability testing which were not validated.
As the Velesco team all come from strong analytical backgrounds, we have each developed numerous stability indicating methods, and performed many method validations and forced degradation studies, so this training provided a very good refresher and confirmed that we know our stuff.