Auditing in a GxP Environment
In order to improve a regulated quality system, an audit process is required. M.P.C.A. International BV offers consultancy advice and application services to allow an audit to be carried out successfully — followed by a detailed report and CAPA support.
Internal & external audit services
Competent authorities increasingly expect pharmaceutical companies to regularly audit their suppliers and service providers as well as their own internal organisation.
Internal Audits
Internal audits, including supplier audits of the full range of products and services purchased, are tools that ensure continuous improvement to the daily core-business activities.
- Full-range supplier audits
- Internal QMS review
- SOP compliance assessment
- Continuous improvement focused
External Audits
External audits, like customer audits or audits by the government, are tools to verify compliance between business processes and procedures and regulations.
- Customer audit support
- Government inspection preparation
- Regulatory compliance verification
- Pre-inspection gap analysis
How we approach every audit
Audit planning & preparation
We define the scope, objectives and timeline of the audit together with your team — ensuring full alignment before the audit begins.
On-site or remote audit execution
Our experienced auditors conduct a thorough review of your processes, documentation and systems — in full compliance with applicable GxP guidelines.
Detailed audit report
Every audit is followed by a comprehensive written report documenting all findings, observations and recommendations — ready for your regulatory files.
CAPA plan & follow-up
We help you establish a Corrective Action and Preventive Action (CAPA) plan and provide follow-up support to ensure all findings are addressed effectively.
Annual Management Review
M.P.C.A. International BV is experienced in performing yearly Management Reviews of your pharmaceutical business — keeping your quality system on track.
Need audit support for your organisation?
Our experienced auditors are ready to help you improve your quality system and ensure full GxP compliance.