the new EMA Q&A document dated 8 April 2025 (“Guidance on Good Manufacturing Practice and Good Distribution Practice: Questions and Answers”) makes direct reference to our business model and outlines specific expectations regarding the assessment of potential conflicts of interest in third-party audits.
We explicitly welcome this development – because the independence of our auditors has always been a key quality standard in our organization.
For over 20 years, we have been conducting independent and reliable third-party audits, making a significant contribution to the safety of pharmaceutical supply chains. At the same time, we are committed to keeping costs as low as possible for our clients – for example, through shared-audit models and the option to purchase existing audit reports.
The EMA guidance states on page 7:
“Potential conflicts of interest may arise from diverse sources and may include […] contract auditors or companies who declare that they stand to make commercial gain from sale or supply of an audit report (particularly to sharing of audit reports between different manufacturing-authorisation holders using the same active substance supplier).”
In light of this, we would like to clearly and transparently state our position:
- Yes, we discuss with audited companies the option of making audit reports available to multiple clients.
- Yes, existing audit reports can – with the audited company’s consent – be shared with additional clients.
- No, our auditors do not receive any bonus or incentive for additional report purchases.
- No, our auditors do not personally benefit from shared reports. They are paid exclusively based on actual audit effort – including optional report customization, which is compensated modestly according to the additional time required.
How we ensure auditor independence:
- All auditors undergo a structured qualification process that assesses technical competence, integrity, and reliability – including a witness audit.
- Each auditor signs our binding Code of Ethics, which states, among other things: “The auditor declines orders where he/she is not completely independent (financially or personally) of the auditee […]. The auditor shall not accept inappropriate gifts or invitations […] which could serve as a bribe or influence or be interpreted as such.”
- Each audit report includes a written declaration of independence from the auditor.
- Our Audit Management Department reviews all reports for plausibility, traceability, and impartiality.
- Our Quality Management System is ISO 9001 certified and fully aligned with the requirements of VDI-EE 6306.
- In more than 20 years, there has not been a single complaint or allegation regarding the independence or integrity of our auditors. Should such a case ever arise, we guarantee immediate, thorough, and transparent handling.
Additional measures in response to the new EMA guidance:
- From now on, each audit report will include a signed declaration of independence from department management.
- Our contracts and audit documentation are currently under review and will be updated where necessary to meet evolving expectations.
If you have any questions about our quality management or the measures outlined above, please don’t hesitate to contact us.
Contact us at audit@heacon.de or visit our Website at https://www.heacon.de/
