Whether you are in the early stages of managing responses to FDA 483 observations, delivering on commitments to FDA as part of a Warning Letter or Consent Decree or, you have successfully satisfied FDA and you are in the end stages of returning to a new state of normal operations, you can never go back. You must maintain your laboratory operations in a state of current good manufacturing practice (cGMP) compliance at all times.

 

Examples of areas in which Regulatory Compliance Associates® Inc. can provide laboratory compliance support include:

 

  • On-site inspections, i.e., Gap Assessment, General GMP, FDA Readiness, etc.
  • Data Integrity Verification, i.e., OOS, OOT, Notebook Audit, Forensic Evaluation, etc.
  • Calibration / Metrology Program Assessment
  • Method Development and Validation Assessment
  • Stability Study Program Assessment
  • WFI Process Verification
  • Risk Assessment for Modifications to Existing Labs or Build Out of New Labs

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