Pharmaceutical Excipients

WHO GMP Guideline for Excipients Used in Pharmaceutical Products

WHO GMP Guideline for Excipients Used in Pharmaceutical Products

The WHO guideline Good Manufacturing Practices: supplementary guidelines for the manufacture of pharmaceutical excipients, was published in the WHO Technical ReportSeries No 885, 1999. As excipients are sometimes used in large quantities in pharmaceutical dosage forms, and may contain impurities, they can affect the quality of a finished pharmaceutical product. The manufacturer of the finished…

Excipients in Pharmaceutical Applications
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Excipients in Pharmaceutical Applications

Pharmaceutical excipients are used in virtually all drug products and are essential for drug product manufacturing and performance. Thus, the successful manufacture of a robust product requires the use of well-defined excipients and manufacturing processes that consistently yield a quality product. The intended end use of the excipient should be identified and considered in determining…