accountThe ability to meet standards and regulatory approval is nowhere more important than in the pharmaceutical industry.
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PHARMACEUTICAL MANUFACTURING
Pharmaceutical manufacturing is a combination of an active ingredient with excipients to produce a dispensable drug. The FDA and other regulatory agencies have set quality standards that resulted in “quality by analysis” manufacturing methods, which add significant cost to the process. Specialty chemicals are produced using “quality by design” methods. Should pharmaceuticals be manufactured using similar methods or is there a more cost-effective way?
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