Cleaning Validation is an FDA-mandated requirement that is considered an essential part of maintaining compliance with current Good Manufacturing Practices (cGMP) for the pharmaceutical and related industries. The primary goal of validating a cleaning process is to prevent product contamination or adulteration, and to demonstrate that manufacturing or process equipment, and associated product contact surfaces, are adequately maintained and free of contaminants, either from environmental conditions, from previous substances used with that equipment, or from cleaning products themselves. Manufacturers are required to maintain appropriate documentation as evidence of cGMP compliance.
As part of our Validation Services portfolio, Robertson Microlit has years of experience in developing equipment cleaning validation approaches, and methodology (typically using HPLC). Our experts can assist with, provide guidance, and provide supportive cGMP-compliant documentation, including:
- Analytical method development and optimization
- Formal method directions for testing
- Method validation protocol
- Method validation report
- Swab selection assistance and compatibility evaluation
- Coupon recovery study protocol
- Recovery study validation report
Robertson Microlit can also provide ongoing routine cleaning verification support for chemical and pharmaceutical manufacturing, and packaging operations.