Auditing
Facility and system audits
Independent GMP audits of facilities, utilities and quality systems, reported with clear findings and practical recommendations.
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Supplier auditing and qualification
Audits and qualification programmes for API, excipient, packaging and service suppliers across your supply chain.
Regulators expect you to know your supply chain and to be able to demonstrate control over it. We audit suppliers and contract partners on your behalf, assess them against GMP and GDP requirements, and help you build a risk-based qualification programme that stays current.
Scope
- On-site and remote supplier audits
- Supplier risk classification and audit scheduling
- Qualification procedures and questionnaires
- Quality agreement review
- Follow-up on supplier CAPA
How we approach it
Risk-based scheduling
Audit frequency follows the risk the supplier presents to your product.
Consistent reporting
Reports follow a standard structure so suppliers can be compared.
GMP and GDP
Distribution partners are assessed against GDP expectations, not only manufacturers against GMP.
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Auditing
Due diligence
Independent assessment of regulatory compliance, quality systems and risk for acquisitions, partnerships and contract manufacturing decisions.
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