Quality Metrics – New FDA Guideline
The term “Quality Metrics” means all those indicators that give an idea of the collective quality characteristics of a certain production site. The number of rejected batches per year compared…
Analytical Method Transfer (USP 1224) Guideline
Analytical Method Transfer (also called ‘Method Transfer’): A documented process that qualifies a laboratory (i.e., the Receiving Unit) to use an analytical test procedure that originated in another laboratory (i.e.,…
HPLC Column Management – SOP & Guideline
Standard Operating Procedure (SOP) and Guideline for Receipt, Qualification, Usage, Regeneration, and Discardation of HPLC/UPLC column. Procedure for Handling of HPLC/UPLC Column 1.0 Purpose : To define the procedure for…
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