Joint Position Paper on Pharmaceutical Excipient Testing and Control Strategies - Pharmaceutical Technology

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Joint Position Paper on Pharmaceutical Excipient Testing and Control Strategies
This article presents collaborative positions among excipient manufacturers, drug product manufacturers, and members of the US Pharmacopeia on key issues pertaining to the control of pharmaceutical excipients stemming from a recent Pharmaceutical Quality Research Institute workshop.


Pharmaceutical Technology


A noncompendial designated component is an article for which an official NF or USP monograph exists; and the article in all probability will meet USP–NF end-product test criteria if and when tested; and an article for which the excipient (article) manufacturer chooses "not to designate" on its label the USP or NF designation or suffix, even when each batch of the excipient would have passed the USP–NF end-product test criteria by a compendial analytical procedure or by an alternative analytical procedure.

A noncompendial analytical procedure is an end-product test procedure that is not described in a pharmacopeia. An alternative analytical procedure is one other than a compendial analytical procedure or other FDA-recognized public standard procedure such as those published in Food Chemical Codex, AOAC International, American Society for Testing and Materials standard procedure, and so forth (20). For a compendial analytical procedure, FDA does not expect to receive analytical methods validation data in a drug-product application. A reference to the official compendial procedure or a FDA-recognized public standard analytical procedure would suffice. Validation data for noncompendial analytical procedures should be made available for inspection at the testing site and need not be submitted in an application.

If a drug-product manufacturer tests every batch of a noncompendial–designated excipient they receive using compendial analytical procedures, then it would amount to a practice of verifying their excipient quality by testing. A substantive issue in that case can be whether the excipient was manufactured under GMP conditions.

At the workshop, it was discussed that some extensively used excipients do not have monographs in USP–NF. On the other hand, there are USP–NF monographs without excipient manufacturers supplying USP- or NF-grade material.

The following excipients used by the pharmaceutical industry do not have current monographs in USP–NF: corn syrup, edetate calcium (calcium EDTA powder), propylene glycol stearate, propylene glycol diacetate, and gentisic acid ethanolamide. Diethyl phthalate, liquid glucose, and lecithin do not have excipient manufacturers producing NF-grade material. Additional supply problems occur with particular grades such as synthetic glycerin. For lecithin, some grades are available, but others are not. USP provides assistance in the form of submission guidelines for an excipient monograph or revision to an existing monograph to USP–NF (21).

Workshop participants agreed that additional guidance from FDA to excipient manufacturers may alleviate some of these issues. USP has already published IPEC guidelines as General Information Chapter ‹1078› "GMPs for Bulk Pharmaceutical Excipients." These guidelines also educate the drug manufacturer with regard to excipient GMP and other expectations.

Reduced testing as a result of the use of compendial harmonization

This topic was described to the participants as:
By increasing the pace of global harmonization, industry stakeholders are expecting to reduce testing significantly. The workshop will assess the status of harmonization and will recommend how to effectively use harmonized monographs, and reduce the testing burden of pharmaceutical excipients.

More than half of excipient manufacturers (59%) and of drug-product manufacturers (55%) reduce redundant testing by selecting the most stringent method or specification for confirming compliance with more than one compendium. About 53% of excipient manufacturers and 74% of drug-product manufacturers stated that redundant testing could be reduced by at least 20%. Only two respondents indicated redundant testing would not be reduced.


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