Compendial Requirements

Q: Do I need to comply with all aspects of the various pharmacopeias? (e.g., United States Pharmacopeia–National Formulary [USP–NF], European Pharmacopoeia [Ph.Eur.],Japanese Pharmacopoeia, etc.)?

A: This would seem like a straightforward answer, but as with most issues related to the pharmaceutical industry, it is a bit complicated. Each pharmacopeia has various sections the industry must comply with including monographs, defining the test methods and purification for excipients, APIs, and drug products. These specific monographs often refer to general test procedures (loss on drying, pH, residue on ignition) that are consistently performed respective of the materials.

The conditions for performing compendial testing are included in the monograph, while the details of how to perform the tests are included in the general chapter. Individual monographs will specify the use of a certified reference standard that serves as the measure to which your specific item should be compared to in determining its suitability for use. It is acceptable to use in-house reference standards as long as the company has mapped its in-house standard to the official standard. The important detail to remember is to requalify your in-house standard when the lot number of the official standard changes.

Not all information in the pharmacopeias needs to be complied with. The USP–NF has a section called general information chapters, which are basic guidance advice for performing various operations such as environmental monitoring. Although these chapters are not legally enforceable, users should take notes and document their process when it conflicts with pharmacopeia’s advice. Like the USP–NF, there are some sections in the Ph.Eur. that are not legally binding. These would be general method analysis of substances used in the manufacture of medicines if they are not referenced in a monogram.

Compendial Standards

The pharmacopeias allow for alternative methods to be used providing they are validated and the results generated from the alternative method yields comparable results to the compendium method. All the pharmacopeias have a process for updating their contents. It is up to the users of the pharmacopeias to make sure they are using the current version published by the governing authority for the specific pharmacopeia. If you follow this simple advice, you should have no trouble maintaining compliance to the compendia requirements.

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BioPharm International
Vol. 36, No. 10
Page: 34