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Good Practices for Research and Development (R&D) Facilities | WHO Guideline

Good Practices for Research and Development (R&D) Facilities | WHO Guideline

With an ever-increasing awareness of the risks in pharmaceutical production and control and the lifecycle approaches being followed, greater emphasis is being placed on ensuring that the research and development of products are appropriately controlled and documented. Consequently, it is necessary that manufacturers of pharmaceutical products are able to submit all relevant data and information…

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…