Quality risk management for product process lifecycle

Integrated Commissioning and Qualification (C&Q) is a powerful verification process.  Validated processes in sectors such as food, manufacturing, pharmaceutical, and bio-tech rely on a thorough C&Q effort to ensure equipment and systems are designed, installed, started-up, and operated per the owner’s requirements, codes, and regulations.

One of the fundamental principles of the process validation lifecycle is that quality must be designed into a process from the beginning.  GMC Commissioning provides early assistance and seamless integration with your validation team.  We follow Good Engineering Practices and Current Good Manufacturing Practice (cGMP). 

AREAS OF EXPERTISE

  • Commissioning and Qualification Plans

  • Impact Assessments

  • User Requirements Specifications (URS)

  • Site Acceptance Testing (SAT)

  • Factory Acceptance Testing (FAT)

  • cGMP Protocol Development and Execution

  • Installation Verification (IV)

  • Functional Performance Testing (FPT)

  • Installation Qualification (IQ)

  • Operational Qualification (OQ)

  • Performance Qualification (PQ)

  • Good Documentation Practices (GDP)

  • Standard Operating Procedures (SOP)

  • Calibration and Asset Induction

  • Issue Tracking and Resolution

  • Leverageable Test Protocols

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© 2020 by GMC Commissioning, Inc.