Whitepaper: ABCs of reference standard management

Reference standards play a critical role in pharmaceutical drug development from preclinical to commercial analytical support.

Bio-analytical methods often require internal, metabolite and active ingredient standards in support of method validation and cGLP testing. Standards that support cGMP testing, such as API impurities, are introduced during clinical trial manufacturing of drug substance and drug product. The management of Certificate of Analysis (CoAs), inventory and supplies to external users, is critical to avoiding delays in drug development.

Here we profile reference standard management and discuss types of standards, standard via synthesis, officially sourced standard, suppliers, characterisation, and impurity testing. In addition, we will discuss standards storage, retesting and sample administration.