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.