The European Medicines Agency (EMA) recently published updated Q&As that emphasize one thing above all: the importance of impartiality in third-party audits. Specifically, so-called “shared audits” — where a single audit report is sold to multiple companies — are now under increased regulatory scrutiny.
What Changed — and Why Does It Matter?
Audit service providers offering shared audit reports must now demonstrate a higher level of independence and declare absence of conflict of interest. When financial gain is tied to the number of audit report sales, the Qualified Person (QP) of the purchasing company must ensure that such incentives do not compromise audit quality or impartiality.
The EMA’s updated expectations emphasize the responsibility of the QP to ensure:
- The audit report is independently written
- Conflicts of interest are identified and documented
- The provider of the third-party audit report is approved
QP Responsibilities: What Must Be Assessed?
When purchasing a third-party audit report, the QP of the MAH/MIAH must approve the report and conduct a documented evaluation. The following criteria are essential:
- Clear contractual arrangements with the audit provider
- Audit scope and duration suitable for the number and type of APIs/products
- Competence and independence of auditors
- Frequency of audits
- Adequacy of CAPA plans and follow-up
- Conflicts of interest — identified, declared, and assessed
If a conflict of interest becomes apparent after purchasing a readily available audit report, a retrospective risk assessment must be carried out.
Preventing Conflicts of Interest in Future Shared Audits
To ensure EMA compliance and protect product integrity, companies should look for the following when purchasing any third-party or shared audit:
- Ideally, an accredited quality system (e.g., ISO 17020) is in place
- Clearly documented procedures to detect conflicts of interest
- A signed declaration of no conflict of interest from auditors
- Adequate audit time, especially when multiple products are covered
- Auditors compensated via fixed contractual fees, unrelated to audit outcomes or sales
- The audit firm who stands to make commercial gain from the sale of the shared audit reports must not influence the audit findings or modify the final report
Diapharm Audit Services – A Proven Model for Regulatory-Compliant Shared Audits
Diapharm organizes shared audits worldwide and commissions blue inspection GmbH to conduct these audits.
This model ensures all EMA requirements on impartiality, independence, and quality are met.
blue inspection is:
- Accredited by the German Accreditation Body (DAkkS) under ISO 17020 for auditing API and excipient manufacturers
- Operating under a quality system that ensures independence, impartiality and confidentiality
- Contractually obligated to avoid conflicts of interest — auditors have no financial ties to audited companies, and must not have previously worked for them
- Paid only under fixed terms, completely independent of audit results or sales of reports
Diapharm does not influence audit outcomes and ensures that all Quality Technical Agreements (QTAs) and contracts address the EMA’s latest expectations.
Summary: A Trusted Framework for Shared Audits
By partnering with Diapharm, pharmaceutical companies benefit from:
✅ Fully EMA-compliant third-party audit processes
✅ Independent and professionally conducted audits
✅ Reduced administrative burden via pre-established QTAs
✅ No compromise on integrity, quality, or transparency
Looking for shared audits that meet all current EMA expectations?
Contact us at Diapharm:
+49 251 609350
audits(at)diapharmREMOVETHIS.com
