Ask the Expert: Complying with Standards

Are Pharmaceutical Companies Required to Comply With Pharmacopeias?

Understanding pharmacopeial requirements can be more nuanced than simply determining whether compliance is mandatory. In this Ask the Expert discussion, Susan J. Schniepp of RCA, a Nelson Labs company and Siegfried Schmitt, PhD, of Parexel explore how pharmaceutical companies should approach requirements and guidance from organizations such as the United States Pharmacopeia (USP) and European Pharmacopoeia (Ph. Eur.).

The experts explain the distinction between compendial monographs, which establish recognized specifications and test procedures, and general information chapters, which typically provide advisory guidance. Companies that choose an alternative approach must be able to demonstrate and document how it continues to meet applicable GMP requirements.

The discussion also highlights the importance of method verification, appropriate documentation, and understanding the distinction between following a standard and demonstrating compliance. Even when using an established compendial method, laboratories must verify that the method performs as intended within their own facilities and systems.

Read the full article and watch the Ask the Expert discussion:
Ask the Expert: Complying with Standards

Link to the Video and Article on Pharmaceutical Technology