Bulk pharmaceutical excipients

Principles of Good Manufacturing Practices for Bulk Pharmaceutical Excipients... 

U.S. Pharmacopeia (USP) (2006), Good manufacturing practices for bulk pharmaceutical excipients, general chapter <1078>, U.S. Pharmacopeial Convention, Rockville, MD. 

In the absence of specific stability guidance from the FDA and ICH (and limited guidance from the WHO) for excipients, the USP GMP guidance for bulk pharmaceutical excipients [4] is used to review stability requirements for excipients. A... 

Drafting of the IPEC good manufacturing practices (GMP) standards for the manufacture of bulk pharmaceutical excipients. The GMP standards were included in USP as General Chapter (1078), and represent the international industry standard for GMPs for bulk pharmaceutical excipients (15). 

Excipients are used in drug substance formulations to provide an acceptable drug product. The FDA considers excipients as BPCs, but has not issued specific GMP regulations for them. The International Pharmaceutical Excipient Council (IPEC), however, issued a proposed GMP for excipients in 1995 and a guide, Significant Change for Bulk Pharmaceutical Excipients BPEs, in the year 2000. 

Good Manufacturing Practices for Bulk Pharmaceutical Excipients. United States Pharmacopeia 24, General Chapter <1078>, 2040-2049 (2000). 

Good Manufacturing Practice Guide for Bulk pharmaceutical Excipients. International Pharmaceutical Excipient Council. Arlington, VA, 1995. 

Mervcill, A. A good manufacturing practices guide for bulk pharmaceutical excipients. Pharm. Technol. (USA) 1995, 19, 34 0. 

USP (1078) good manufacturing practices for bulk pharmaceutical excipients. In United States Pharmacopeia, 24th Ed. US Pharmacopeial Convention, Inc. Rockville, 2000 2040. 

Good Manufacturing Practices (GMP) Audit Guideline for Distributors of Bulk Pharmaceutical Excipients. 

The IPEC-Americas Safety Guidelines (modified) are presented as an information chapter in United States Pharmacopoeia (USP) 24/NF 19. The Good Manufacturing Guide or Practices for Bulk Pharmaceutical Excipients also has been published as an information chapter in USP 24/NF 19. The guideline also... 

Good Manufacturing Practices Guide for Bulk Pharmaceutical Excipients The International Pharmaceutical Excipients Council Arlington, VA, 2000. 

The International Pharmaceutical Excipients Council Guideline for Distribution of Bulk Pharmaceutical Excipients, 2000. 

REEVALUATION DATE That date beyond which the bulk pharmaceutical excipient should not be used without prior adequate reexamination. 

International regulations governing drugs require that components of the drugs be manufactured, processed, packed, and held in accordance with GMPs. Unlike other pharmaceutical products and components, there is no guidance that specifically addresses the manufacture of bulk pharmaceutical excipients (BPEs). 

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