Auditing
Supplier auditing and qualification
Audits and qualification programmes for API, excipient, packaging and service suppliers across your supply chain.
Learn moreAuditing
Facility and system audits
Independent GMP audits of facilities, utilities and quality systems, reported with clear findings and practical recommendations.
An external audit gives you an honest view of compliance before a regulator or customer forms one. Our auditors assess the facility, supporting utilities, production and laboratory operations and the quality system against the applicable GMP requirements, and report findings graded by risk.
Audit types
- Full-site GMP audits
- Focused system audits (for example data integrity, laboratory controls or sterility assurance)
- Pre-approval and pre-inspection readiness audits
- Follow-up audits to verify CAPA closure
How we approach it
Risk-graded findings
Observations are classified so you can prioritise the response.
Practical recommendations
Each finding comes with an actionable recommendation, not only a citation.
Confidential
Audit reports and observations stay with you.
Related services
Auditing
Due diligence
Independent assessment of regulatory compliance, quality systems and risk for acquisitions, partnerships and contract manufacturing decisions.
Learn more