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cGMP Consulting uses a Risk Based Approach (RBA) to Qualification that aligns with the current FDA thinking on qualification. This process is well defined and frontloads much of the activities. This approach allows for greater flexibility in optimizing system performance before implementing the systems on the line. RBA focuses qualification on the functions that have the greatest impact on and create the greatest risk to production.

The standard process includes the following steps:

  • User Requirements Specifications (URS)Functional Specifications (FS)

  • Risk Analysis / Failure Modes Effects Analysis (FMEA)

  • Factory Acceptance Testing (FAT)

  • Commissioning / Site Acceptance Testing (SAT)

  • Installation Qualification (IQ)

  • Operational Qualification (OQ)

  • Performance Qualification (PQ) | Give us a call at 312-420-7682