Ask the Expert: Complying with Standards

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In this episode of Ask the Expert, Susan J. Schniepp, distinguished fellow with Nelson Labs, and Siegfried Schmitt, PhD, vice president, Technical, with Parexel answer the question of whether pharmaceutical companies must comply with pharmacopeias, such as the United States Pharmacopeia (USP) and European Pharmacopoeia (Ph.Eur.). The answer is not a simple yes or no.

Schniepp explains that pharmacopeial monographs, which are specifications and test procedures, are validated, recognized by regulators under good manufacturing practices (GMPs). In the United States, USP defines a monograph as “a written document that reflects the quality attributes of medicines approved by the US Food and Drug Administration” that provide quality expectations and include tests and information regarding identity, strength, purity, and performance.¹

However, "general information chapters" offering broader guidance are generally considered advisory rather than mandatory. Companies may deviate from these recommendations, but must document and justify how their alternative approach still achieves GMP compliance.

Schmitt notes that the USP is developed by a non-government organization; however, the European and Japanese pharmacopeias are government-issued, making them more directly enforceable. He points out that there are other voluntary standards (e.g., GAMP, ISO, ANSI, and NIST) and organizations like the Parenteral Drug Association operate within an ANSI-accredited framework, issuing technical reports and white papers as best-practice guidance where official standards don’t exist.

Schmitt and Schniepp stress that merely citing a standard (e.g., "we followed GAMP") doesn't guarantee compliance. According to Schmitt, there have been cases where companies claimed adherence but lacked the required documentation such as validation plans.

Schniepp adds that adopting a compendial method still requires labs to perform their own verification, because original validation data come from the submitter (government or innovator), not the adopting lab. Variations from lab to lab, such as equipment differences (e.g., high-performance liquid chromatography vs. ultra-high-performance liquid chromatography), requires that labs must confirm the method works on its own systems, essentially a mini robustness check.

Schmitt brings up an interesting point manufacturers should consider. In China, companies must maintain the original-language pharmacopeia and demonstrate someone can actually read it, because translations may be inaccurate.

Compendial compliance is nuanced, requiring companies to interpret regulations, verify methods locally, and document deviations rather than assume automatic compliance.

Click on the above video to watch Sue and Siegfried answer the following question:

“We have just acquired the latest versions of the United States Pharmacopeia and the European Pharmacopoeia. We are not clear if it is mandatory to comply with these pharmacopeias. Do we need to comply?”

Reference

1. An overview of USP monographs. USP. Accessed August 5, 2026. https://www.usp.org/about/public-policy/overview-of-monographs

About the Experts

Susan J. Schniepp is distinguished fellow at Nelson Labs and a member of PharmTech's Editorial Advisory Board.

Siegfried Schmitt is vice president, Technical at Parexel and a member of PharmTech's Editorial Advisory Board.