Triggering Of Any International Regulatory Audits

Preparation and submission of audit compliance reports for regulatory agencies like MHRA, USFDA, TGA, MCC, AFSSAPS & WHO, by establishing the following:

  • SYSTEMS assessment
  • Evaluate appropriate written procedures and adherence.
  • Additional systems to be inspected.
  • Drill down technique used
  • Ensure effective systems to avoid insignificant failures
  • Ensure effective systems to avoid significant failures

Salient Features

  • Evaluate if QA unit has reviewed and approved all procedures related to production, QC and QA.
  • To assure the procedures are adequate for their intended use (including associated record keeping systems).
  • To assess the data collected to identify quality problems (may link to other major systems)
  • To assure compliances with –
    a. Submission commitment.
    b. Good Manufacturing Practices.