Many early-stage projects fail in clinical trials, so anything that can possibly help to beat those odds is prudent.
If you’re interested in learning more about process validation, check out our article here. Ed is the President and CEO of PCI Synthesis (PCI), he serves as a co-chair of the New England CRO/CMO Council and sits on the Industrial Advisory Board for the Department of Chemical Engineering at UMass, Amherst.
A key analytical technique employed in an analytical laboratory is chromatography.
In chromatography, organic and inorganic compounds are separated so that they can be analyzed and studied to determine what makes up that compound.
Ed is also a long standing member of the American Chemical Society and advises the Bulk Pharmaceutical Task Force of the Society of Chemical Manufacturer’s and Affiliates (SOCMA).
Qualitative By Dave Collingridge I remember years ago walking the halls of the faculty offices at my university asking for help on validating a questionnaire.
When a manufacturer qualifies an analytical method, it is simply assessing that it is suitable for its intended purpose.
It compares specific samples of the compound to a standard one to test its reproducibility.
It typically takes three weeks to validate a single method, at a cost in the range of -30K.
This applies to laboratories using published standard test methods, modified standard test methods, and in-house test methods.
Although a collaborative study is part of this guide, this guide may be used by a single laboratory for method validation when a formal collaboration study is not practical.
Analytical procedures are necessary to ensure the identity, strength, quality, purity, and potency of a drug substance and drug products.
In order to file a substance for commercialization with the FDA, a manufacturer must include a full description of the manufacturing process, including the analytical procedures that prove the manufactured product meets prescribed standards.