Cleaning Validation

  • Do you know what are the various elements of a cleaning validation program?
  • How do you know if these elements have been established and implemented in a way that will pass the scrutiny of regulatory audits?
  • Do you know how many FDA Warning Letters / Form 483 have been issues because of cleaning validations in the last 5 years?
  • How do you know that your cleaning validation program documentations are complete and compliant?
  • Do you have the time/resources to address the most common issues in a cleaning validation process?

Synergy Bioscience can help you develop a robust and compliant cleaning validation program consistent with best practices and the regulatory requirements. We will design a risk-based and science-based cleaning validation strategy that eliminates contamination risks that may contribute to poor product quality. We will produce a complete list of residues, cleaning agents and other materials that could contaminate your equipment during the manufacturing process. We will also develop the right methods that will identify and quantify any residues remaining after your manufacturing equipment have been cleaned. In addition, we will perform residue detection, quantification and identification, method development and validation and residue acceptance criteria development, using our state-of-the-art GMP certified Laboratory.

At our cGMP certified analytical laboratories, we ensure that fit-for-purpose analytical methods are developed. These methods are specific for the substances being assayed and suitable to detect contaminants at the specified acceptable level. Upon your request, our cleaning validation programs will include analytical method development, validation, and transfer. Our cGMP compliant laboratories are equipped with a wide range of techniques for both non-specific and specific API assays including high pressure liquid chromatography-mass spectrometry (HPLC-MS), ion chromatography (IC), inductively coupled plasma spectroscopy with mass spectrometry (ICP-MS) detection, Total Organic Carbon (TOC), and Gas Chromatography – Mass Spectrometry (GC-MS), to just name a few. Bringing quality and safety to life, we offer Total Quality Assurance expertise to help you meet and exceed quality, safety and regulatory standards.

By partnering with Synergy, you don’t have to outsource your cleaning validation activities to many outside sources because we can help you from start to finish, as we have the industry-proven validation consultants who are experienced in all aspects of Process and Cleaning Validation and state-of-the-art cGMP laboratory instrumentation. Whether it is initial process validation for a new process, scale-up, or remediation, we will provide you with all you need to ensure all quality and compliance requirements are met.

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