Technical Services for Manufacturers of Pharmaceuticals and B​iologics

GMP Contracting, Inc.

 

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​Matt Bestercy     (631) 838-9083       mbestercy@bestgmp.net
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Commissioning/Validation

We help you decide what to validate using sound, documented scientific rationale. We leverage commissioning activities to avoid duplication of testing under qualification. Only systems having direct product quality impact are qualified. All other systems are properly commissioned. Our validation experience is broad:

Commissioning & Qualification:

  • Process Equipment
  • Facilities/Utilities
  • Commissioning & Qualification
  • Packaging Equipment and Line Qualifications
  • Temp/RH Mapping

Validation:

  • Process Validation
  • Cleaning Validation
  • Analytical Method Validation
  • Aseptic - Sterilization & Media Fills
  • Gas Assessments & Remediation

Systems:

  • Master Plans
  • Policies
  • Procedures
  • Project Management
  • Validation Training
  • Change Control
  • Periodic Review

Engineering Support Systems:

  • Calibration and Preventative Maintenance Procedures and Policies
  • ​CMMS Database Setup and Validation