USP and the European branch of the International Pharmaceutical Excipients Council (IPEC-Europe) have both released guidance for pharmaceutical companies on the evaluation and handling of excipient distribution.
USP published for comment in “Pharmacopeial Forum,” PF 37 (6), available on its website, a draft of a general chapter <1197> that has been developed on “good distribution practices for bulk pharmaceutical excipients” (link provided below). Comments are due by January 31.
Formed at the request of USP’s Excipients Expert Committee, the <1197> Expert Panel that developed the draft proposal was global in makeup with volunteers from the United States, China, Germany, and Jordan.
Excipients are used in virtually all drug products and are essential to product performance and quality. Typically, excipients are manufactured and supplied to comply with compendial standards.
The quality of pharmaceutical excipients can be affected by the lack of adequate control of activities including distribution, packaging, repackaging, labeling, and storage. “Improper or inadequately controlled trading practices,” USP cautions, “can pose a significant risk to the quality of pharmaceutical excipients and can increase the risk of contamination, cross-contamination, adulteration, mix-ups, degradation, or changes in physical or chemical properties.”
In the introduction to the draft, USP notes that the “proposed general information chapter provides key information to help assure excipient quality and help prevent economically motivated adulteration.”
The chapter outlines “key strategies necessary in the qualification of starting material of good quality, the maintenance of that quality throughout the distribution chain and the confirmation of the quality by the users of starting materials.”
The 56-page draft includes sections covering: ● introduction and scope ● quality, organization and documentation ● premises, storage, repackaging and stability ● returned goods, dispatch, transport, importation, adulteration and traceability, and ● excipients used in pharmacy compounding. An appendix is attached providing related definitions/acronyms.
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