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.