Cleaning Validation

Based on our experience, anything that can get into a drug product, will. Potential types of contaminants include degradation products, cleaning agents, microbiological agents, excipients, foreign solvents, and even manufacturing materials. Any material involved in manufacturing a drug product has the potential to become a contaminant. Compliance difficulties encountered in today’s cleaning programs, include:

  • Inadequately written cleaning procedures
  • No scientific justifications for establishing the limits for the cleaning process.
  • Failure to identify most to clean spots
  • Sampling and analytical issues associated with cleaning
  • Inadequate documentation of validation of cleaning
  • Not including cleaning under the change management program

But the question is how to identify, detect and quantitate those contaminants? Synergy Bioscience can help you develop and implement a robust and comprehensive cleaning program that can withstand the FDA regulatory inspection and review.

To discuss how Synergy Bioscience can help you, please contact us.

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888 – 588 – 6704

408 – 228 – 7193

469 – 304 – 9272

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