Regulatory Aspects of Excipient Quality Assurance

All the acceptance criteria and test results are best expressed numerically or qualitatively (e.g., clear, colorless solution), as appropriate. The use of terms such as conforms or meets specification is discouraged. 

When the specification for a compendial excipient differs from the compendial monograph (e.g., additional tests, different analytical methods, or different acceptance criteria) the test results will be accepted from the excipient manufacturer s COA. However, the excipient should still conform to the monograph in an official compendium if there is such a monograph otherwise, justifications must be provided, and labeling needs to be changed to state plainly that the article does not meet the compendial requirement. 

The drug product manufacturer must establish the reliability of the supplier s analyses through appropriate validation of the supplier s test results at appropriate intervals per [21 CFR Part 211.84(d)(2)]. The reliability of the analyses need not be established at the time the application is submitted. However, the specification should indicate that the tests that will be performed once the reliability of the supplier s results has been established in accordance with cGMPs, prior to marketing the drug product. 

A compendial excipient should comply with the current revision of the official compendium cited. Therefore, when citing an official compendium, the version of the compendium should not be included in the citation. For example, the NF should be cited rather than NF 20. Certain General Chapters in the USP contain a statement that the text of the USP is harmonized with the corresponding texts of the European Pharmacopoeia and the Japanese Pharmacopoeia. However, where a difference appears, or in the event of a dispute, the result obtained from the USP procedure is conclusive. 

ICH Q6A Specifications Test Procedures and Acceptance Criteria for New Chemical Substances and New Drug Products. 

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