We Guarantee

• Highest level of independence with Europe's only 4-way audit system.
• Type A accredited audits.
• Highest quality.
• API audits by qualified auditors.
• Comprehensive API audit reports.
• Confidentiality on all levels and guaranteed absence of conflict of interest.
• Assessment of CAPA plan and CAPA declaration.
• All costs included (e.g. travel expenses and translators).
• Acceptance by authorities worldwide.

Your Benefits

• Time and money saved on audits.
• Independent, high-quality verifications of GMP compliance of manufacturers.
• Decreased workload for the qualified person.
• Internationally recognised API audit reports.
• Reduced number of audits for both Manufacturing Authorisation Holders and API suppliers.

Highest Quality

Our accredited third-party API audits meet the highest standards and are performed by an independent ISO 17020 (type A) accredited auditing company to ensure the highest quality, independence and acceptance by authorities worldwide.

This auditing company is Blue Inspection Body. They are accredited by the German accreditation body (Deutsche Akkreditierungsstelle). Lema Project Management LLC coordinates audits conducted in a four-way system in which auditors are financially independent of both active ingredient suppliers and customers. Provide an audit report separate from the audit results.

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