In the past few days, the European Medicines Agency (EMA) provided important clarifications regarding the use of third-party Good Manufacturing Practice (GMP) audit reports. This is a topic that has long been part of compliance strategies but is now under sharper regulatory focus.

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Two key questions addressed by EMA (Q&A #3 and #9, under EU GMP guide part II: Basic requirements for active substances used as starting materials: GMP compliance for active substances) outlined the conditions under which third-party audits are acceptable, and what is expected from the written final assessment performed by Qualified Persons (QPs).

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EMA emphasized that while audits carried out by independent third parties can be used to verify GMP compliance, this is only acceptable when strict conditions are met. These include auditor independence, robust qualifications, impartiality, and a thorough evaluation of audit findings by the QP. This puts a spotlight on the quality and completeness of the third-party audit report itself and on the integrity of the audit process.

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At Owlpharma, we fully support this regulatory direction. In fact, our audit service model has long been structured around these very principles, which we consider essential.

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Our audit reports are designed to provide a detailed, structured, and GMP-focused evaluation, ensuring that every relevant point is covered, from critical manufacturing controls and quality management system processes to cleaning validation and qualification of equipment and facilities.

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We maintain strict independence from the auditees. Our audit services are commissioned by the client and a statement of absence of conflict of interests is shared together with the audit report.

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All our auditors undergo an internal qualification program which includes the attendance of one IRCA certified lead auditor course. They operate with full independence and undergo continuous training to stay current with the latest regulatory developments.

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Additionally, our commitment doesn’t stop at the audit report. We monitor the process from end to end, from planning and on-site execution to the evaluation and follow-up of CAPA plans. In addition, a complete overview of the audit status can be monitored through our platform AuditSearch.

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This ensures that QPs have access to a complete, timely, and well-documented package to support the written final assessment now emphasized by the EMA.

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Last, but not least, our operations are underpinned by an ISO 9001 certified Quality Management System, reflecting our commitment to Quality and continuous improvement. The same quality culture we expect from the sites we audit, we apply to ourselves.

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Despite the controls we have in place, we are improving our process in the sequence of the abovementioned clarifications. We are now preparing a new version of our statement of absence of conflict of interests, with additional details, providing more information to the QPs evaluating our audit report.

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As always, Owlpharma will cheer for any regulatory guidance centered in improving public health and we will remain a trustworthy partner for any specific query you have along the way.

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Contact us today and we will gladly help you to ensure compliance of your audit process.

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