Preparation and submission of audit compliance reports for regulatory agencies like MHRA, USFDA, TGA, MCC, AFSSAPS & WHO, In-House Inspection, External Party Inspections 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
- Submission commitment.
- Good Manufacturing Practices.
- Define CAPA and make sure it’s implementation.
- Make a gap and risk analysis assessment, Reconciliation of all discrepancies.
- Significant experience in assisting pharmaceutical companies to achieve GMP-compliant quality management systems. Our quality assurance consultants help identify quality system requirements for full GMP compliance.
- We work with clients directly or indirectly as required to identify and develop a relevant quality management system and appropriate documentation set.
- Perform QA and GMP compliance audits and advise clients on the best QMS for their needs.
- Help companies obtain a successful conclusion to regulatory agency inspections through thorough preparation, ongoing consultancy and support to in-house experts, plus on-site support during the inspection itself.