Quality System Project Management

Pre-inspection readiness activities and follow-up:
CGMP Pro will identify areas and items that appear to need improvement, work with you in designing a schedule to address these, and follow up with assuring that documents are updated to incorporate the changes.

Post-inspection action plans:
At the conclusion of the regulatory inspection, normally commitments are made to the agency to address issues that were brought up, either formally in a 483, or verbally by the inspector. Such verbal issues are often written in the inspection report, so that a record exists. CGMP Pro works with you in setting up an action plan to address the issues, corresponding with the agency to assure that the plan is acceptable, and follow up to assure the documentation is updated to reflect current status.

Regulatory action follow-up:

• 483 responses & follow-up
• Design programs to help you achieve an acceptable CGMP compliance status with FDA
• Liaise with FDA for agreement on a corrective action plan
  

No one wants to be in this position, but if you find yourself on the wrong side of a threatened or accomplished regulatory action, then we can help you to put things right with the FDA. It is impossible to state exactly what is needed as each situation is unique, but we will work with you in finding an acceptable solution to the problem.