cGMP Testing

Analytical Testing under current Good Manufacturing Processes (cGMP)

 

Impact Analytical operates with an extensive quality system which allows us to provide comprehensive cGMP and GLP testing services.  We are FDA registered and well versed in the FDA and EPA’s GLP/cGMP regulatory guidelines.  Our robust quality system and experienced analytical professions combine to produce accurate, compliant and on time results that you can trust.  Our qualified instrumentation, analytical expertise and full-time quality staff will ensure your product and data comply to all FDA and/or EPA guidelines. 

 

Examples of our cGMP services include:

  • Contaminant Identification
  • Active Ingredient and API Characterization
  • cGMP Method Development, Validation and Transfer
  • Routine Quality Control Analysis of Raw Materials
  • Development Support
  • Clinical Release Studies
  • cGMP Stability Testing

We have cGMP qualified instruments in the following laboratories:

 

Liquid Separations Lab

Gas Separations Lab

Molecular Characterization Lab

 

 

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