Frequently Asked Questions
Frequently Asked Questions
GxP audit services involve a thorough evaluation of an organization’s compliance with Good Practice (GxP) regulations across areas like manufacturing (GMP), clinical (GCP), and laboratory (GLP) practices. These audits ensure that your processes meet industry standards and regulatory expectations.
GxP auditing helps identify potential compliance gaps, ensures product safety and efficacy, and prepares your organization for regulatory inspections. Regular GXP audits minimize business risk and enhance trust with clients and regulatory bodies.
GxP audit services typically include:
- On-site and remote audits
- Review of documentation and SOPs
- Staff interviews and process walkthroughs
- Detailed audit reports and corrective action plans
- Follow-up support to close findings
Industries such as pharmaceuticals, biotechnology, medical devices, and clinical research often require GxP consultancy. These services ensure that your operations align with global regulatory standards, such as FDA, EMA, and ICH guidelines.
It’s recommended to conduct internal or third-party GXP audits at least annually or more frequently, depending on the nature and complexity of your operations. Risk-based scheduling is often used to prioritize audits.
GxP consultancy firms provide expert guidance, mock inspections, and documentation review to ensure your team is well-prepared for regulatory audits. Their experience helps reduce audit findings and improve inspection outcomes.