The prospect of a regulatory audit can be rather daunting. Regulatory audits are stressful. One of the main sources of stress is fear is the unknown. An audit is only snapshot in time of your operations therefore although you try, you cannot and will not be able to prepare for everything that may be part of the inspection.
Key Tips towards success include but are not limited to:
- Make sure your documentation is good order, traceable and available
- Your SOPs are compliant, current and compliant
- Critical Quality incidents are documented, investigated, and have appropriate corrective actions and preventative actions assigned
- Ensure these actions are implemented and monitored to show effectiveness.
- Validate critical processes and procedures
- Qualify Equipment
- Train staff effectively
- Document and justify any risk assessment decisions you have madeYour self – inspection program and regular review and trending of your quality incidents will help you maintain compliant
- operations. Use it to identify recurring incidents and identify opportunities for improvement on an ongoing basis.
PMcG consulting offers an auditing service to help you prepare for a regulatory GMP audit, or pre-licensing audit for GMP activities. We can also act as your QA to audit your internal QMS and perform your self-inspection modules.
On the post audit side, PMcG Consulting can help you prepare a response to a regulatory audit and help you find and implement solutions to the observations you received.
For more information on how we can help you: Contact us