Audits and Validation

ChemRite maintains an extensive audit and validation program for all processes and equipment. We are capable of process validation, cleaning validation, test method validation, and full gauge R&R (reliability & reproducibility). Our audit program consists of three main levels – government, customer and internal.

As an OTC approved production facility, we regularly undergo FDA audit and inspection. We are also a cGMP compliant facility, a high-standards designation we proudly hold. ChemRite encourages customer audits and welcomes customer feedback.

Although we value government and customer audit procedures, ChemRite doesn’t wait for an external audit to correct potential quality issues. Through means of our CAPA (Corrective Action) and CQI (Continuous Quality Improvement) protocols, we identify and correct areas of improvement before they become a concern. ChemRite regularly submits itself to a monthly 387 point full facility inspection which leaves no corner of our facilities without scrutiny.

Validation Capabilities:

  • Process Validation
  • Cleaning Validation
  • Test Method Validation
  • Full Gauge R&R (Reliability & Reproducibility)

Audit Methods:

  • Government Audits
  • Customer Audits
  • Internal Audits