How to ensure the highest level of independence in audits (of APIs)

The different audit options

What are the different models of auditing and which one proves to guarantee the most independence? Here are the various models:

• 1^st Party Audit
  The audit is performed within the manufacturer’s organisation – using its own standards and measuring against external standards. However, one-party or “self-audits” are not acceptable as a proof of GMP compliance for the authorities.
• 2^nd Party Audit
  In this the client audits the manufacturer directly. However, in this case where the auditor is also the client it cannot be guaranteed that there is no commercial influence on the audit.
• 3^rd Party Audit  
  The client orders an external or third-party auditor to perform the audit. The external auditor may commercialise the audit report. In some cases, even the API trader is commissioned as a 3^rd party or “external” auditor. Again, this option is less acceptable for the authorities, especially if the auditor has a direct commercial interest in a positive outcome of the audit.
• 4^th Party Audit
  The client orders the audit with a service provider who commissions an independent company to perform the audit at a manufacturer on their behalf. The service provider, but not the auditor itself, may also commercialise the audit report. The fact that the audit is outsourced proves there is no influence on the audit by any side, and therefore is the best option for all parties involved.

How does this fourth-party audit work?

The service provider outsources the audit to be performed and the client is not involved in any direct communication with the manufacturer regarding the audit. The client may issue their queries to be addressed in the audit to the service provider who ensures that the client’s requirements are met. However, any commercial interest between the client who purchases the product and the manufacturer who sells the product is completely omitted from the equation.

In commissioning an independent auditing company to perform the audit on their behalf, the service provider will receive the audit report no matter the outcome of the audit and can pass this on to the client.

Accredited audit

An auditing company which is accredited to the highest level (Type A ISO I7020), for example by a German accreditation body, works according to the strictest of criteria. Their standard is to perform audits by qualified auditors with sufficient on-site time and to issue product-specific reports following internal review of the reports. They have a quality management system in place, the absence of conflict of interest of the auditors is guaranteed, and they regularly train their auditors. This raises the standard of audits to the highest level and ensures that regulatory requirements are met.

Last but not least, the acceptance of audit reports by authorities worldwide is paramount when taking into consideration what type of audit to pursue.

No influence and highest level of independence

The highest level of independence and complete absence of conflict of interest can be proven to authorities with a four-party audit system which involves the client, the service provider, the auditing company and the manufacturer.

Putting an extra party into the equation reduces any element of doubt and erases the possibility of any influence on the audit itself.  The auditor is obliged to deliver an independent and honest examination of the manufacturer. This is only possible when the auditor himself is completely independent and is paid no matter the outcome of the audit; the auditor is neither influenced by the manufacturer nor the client. 

Instead of just two (client and manufacturer) or three (client – auditing company –  manufacturer) parties involved, a four-party system is an ideal solution. The “fourth” party can be a service provider who organises audits on behalf of one or several clients. In this way, the service provider will receive the audit report no matter the outcome of the audit. Therefore any influence on the audit by any of the parties involved is prevented.

Quality audits from a service-provider can also be a cost-effective solution for clients when it comes to audits performed on behalf of several clients at once.

To learn more about our own 4-way /-party audit system and the high quality audits performed by an independent and accredited company, please contact us here at Diapharm: audits(at)diapharmREMOVETHIS.com.

More information on API audit reports from Diapharm >>