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
- 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.