Many organizations view their QC program as a necessary evil- required by regulatory bodies and useful primarily to release product. However, defining and building a solid Quality Control program can unlock great value. Setting aside the need for finished product release testing and regulatory submissions, the analytical piece in your QC program can deliver you crucial data that can objectively drive decisions concerning Process Validation, Specification Setting, Expiry Dating, and in some cases Supplier Qualification. The primary goal of any QC program is producing timely and accurate data consistently and a solid analytical method qualification and validation approach is your roadmap for success.
Additionally, a well-designed Stability Program can also deliver data for key business decisions. The potent combination of ICH Q1A(R2), the pharma-centric guideline for stability (well established and familiar approach) and CLSI EP25-A, the IVD-centric guide (more practical approach with great examples and definitions) make a very straight forward proposition in study design. Accelerated Stability Studies, in particular, can be used like an Early Warning Detection System. That batch of drug product where you had to use three tail-end API lots? You will want to know, right now, how it might perform in twelve months. The lot of IVD cartridges that sat on the tarmac for 18 hours in the hot sun? Data from your accelerated study could be key in the disposition of this lot for further use.
Improving your QC program can deliver critical data for decisions that impact the bottom line.
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