IMPROVED EXCIPIENT ANALYSIS AND CONTROL
This article was originally published in The Gold Sheet
...is being targeted as a key element in advancing quality by design and quality systems in pharmaceutical manufacturing. Excipient suppliers, users, pharmacopeias and regulatory agencies are searching together for ways to open communication pathways so that better analytical choices can be made and GMP needs clarified and met. A recent Product Quality Research Institute workshop on excipient testing and control strategies assessed the current communication challenges and the efforts under way to address them. [A report on Wyeth’s work on excipient QbD under FDA’s CMC pilot program is included.]
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