Validation Process
Validation is a critical part of establishing and confirming the capability of a client’s utilities, facility, equipment and process to reproducibly deliver a quality product. Compass Biotechnology can help you evaluate your specific situation, properly identify critical areas which can impact product quality and require validation, and then strategically implement a lifecycle approach to ensure compliance in these areas:

Process Validation (PV, PQ)—

  • Identify Critical Parameters;
  • Establish realistic operational ranges;
  • Strategically implement during clinical development.

Cleaning Validation and Sterilizing Validation—

  • CIP and SIP optimization;
  • Autoclave;
  • TOC based approach;
  • Multiproduct changeover cleaning strategy

Viral Clearance Validation—

Equipment Qualification (IQ, OQ, IOQ)—


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