Good manufacturing practices guide pharmaceutical excipients

The IPEC Good Manufacturing Practices Guide for Bulk Pharmaceutical Excipients, 2001. [Pg.388]

Good Manufacturing Practice Guide for Bulk pharmaceutical Excipients. International Pharmaceutical Excipient Council. Arlington, VA, 1995. [Pg.1592]

Mervcill, A. A good manufacturing practices guide for bulk pharmaceutical excipients. Pharm. Technol. (USA) 1995, 19, 34 0. [Pg.1621]

This chapter will deal with the objective of manufacturing excipient ingredients to appropriate good manufacturing practices (GMP) requirements, as stipulated by the United States Pharmacopeia (USP) (1) and the International Pharmaceutical Excipients Council excipient GMP guide (2). It is beyond the scope to address the many quality techniques for minimizing variation in excipient quality. However this chapter will address the issues concerning assurance that all excipient material within each batch meets compendial or manufacturer s specification. [Pg.373]

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... [Pg.1656]

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