Effective management of regulatory Inspections is critical to their outcome and your success. If you are new to regulatory inspections or if you would like to improve your ways or working, we can assist. We have extensive experience of regulatory Inspection Management- both hosting and executing inspections. We can offer solutions and training to improve how you handle Regulatory Inspections and their complexities.

• We can provide advice on how to optimise your Inspection management processes and ways of working. We can offer on-site support to suit your needs.
• Inspection Management design & implementation
• Coaching & dry runs of topics
• Back-room operational support

FAAUZ Pharma designs audit and corrective action plans to accommodate our client’s needs, including MHRA, EMEA, Health Canada and FDA regulations.

We offer the following services but not limited to:

• Internal Audits
• Pre-Approval Inspections
• Contract Manufacturing GMP Audits
• Vendor Audit
• API Manufacturer Audits

During our audit process, we evaluate your existing quality systems, and provide an exact assessment on the company’s various systems. FAAUZ Pharma then recommends a plan of corrective action, which allows the company to achieve the quality assurance required by the respective regulatory agencies.

A pharmaceutical auditing plan may include corrective actions on:

• Documentation and Record Control
• Change Control
• Manufacturing Process and Equipment
• Training
• Validation and Qualification

Pharmaceutical auditing expertise includes writing and review of validation policies, guidelines, site master validation plan and SOP from design qualification to performance qualification steps.