Friday, October 24, 2008

Residual Solvent Coalition Formed - Gets FDA Attention On USP Chapter 467

When the FDA published its recent guidance document on residual solvents in drug products, it resulted in confusion and generated many questions. This recent PharmTech Talk post does an excellent job of framing the difficult situation, "Residual Solvent Concerns Lead to Coalition." In a nutshell, here are some of the important points PharmTech Talk makes . . .

  1. Industry has experienced a number of problems and confusion regarding the draft guidance and communications received from FDA’s Office of Generic Drugs, that seem to conflict with Chapter 467
  2. There have been so many problems that some core industry groups formed the Coalition for Rational Implementation of USP General Chapter <467>
  3. The coalition had four key areas of concern: 1) testing versus control, 2) identification of Class 3 solvents, 3) use of Class 1 solvents, and 4) need for immediate relief while awaiting revised guidance.
Stay tuned, as there's hope the FDA will respond within the next couple of weeks.

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The Health, Drug, Prescription, and GMP Supersite: New FDA Guidance - Residual Solvents in Drug Products

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