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Article: 7 of 11 compendial chapters in Q6A seen harmonized.(Brief Article)
- Article from:
- Validation Times
- Article date:
- June 1, 1999
- Author:
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Seven of 11 pharmacopeia chapters necessary to advance Q6A, the International Conference on Harmonization (ICH) guidance on drug specifications, are "essentially harmonized," industry was told June 11.
U.S. Pharmacopeia (USP) Senior Scientist Dr. Roger Dabbah, Ph.D., said the chapters closest to harmonization by the Pharmacopeial Discussion Group (PDG) discuss sterility, residue on ignition, bacterial endotoxins, color/clarity, particulate matter, dissolution (apparatus) and disintegration (apparatus).
He told a Barnett/Parexel conference in Arlington, VA, that the three remaining chapters -- microbial contamination, uniformity of content and uniformity ...