Eimear Schulte
Associate Director Global Audit Solutions
Attempts to pool or share audits sometimes fail due to the lack of transparency in the system. They can fail due to a non-guaranteed objectivity in the performance of the audit, in the evaluation of the manufacturer, in the writing of the audit report and last but not least if there is no guarantee of independence of the chosen auditor.
A four-way audit system solves all of these problems. The bonus of having four parties involved guarantees independence of the auditing company and supports transparency in this type of audit system. Not only are the customers’ regulatory requirements met, they also receive the highest quality report available on the market.
As the only service-provider organizing 4-way system audits, Diapharm coordinates requests by customers for APIs and organize audits by an ISO 17020 type A accredited inspecting company at the manufacturing sites. All APIs are audited according to the audit criteria of EU GMP Part II. Diapharm is a leading global consulting firm and service provider for the consumer healthcare and pharmaceutical industry. Its work focuses on regulatory affairs and marketing authorization, medical and scientific tasks, quality assurance and consulting.
At Diapharm, the resulting audit report is available for the manufacturers’ customers.
Diapharm’s 4-way audit system is a third-party audit solution with 4 parties involved: the client purchasing the API, the service-provider (Diapharm), a fully independent 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 organizes 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.
This has turned out to be the best solution for customers to comply with international regulations, because the auditor is independent not only of the manufacturer but also independent of the purchaser of the API. Diapharm receives the resulting audit report from the auditing company regardless of the outcome of the audit.
In addition to the general benefits of a third-party audit, this unique 4-way audit system offers further advantages for both manufacturers and their customers:
This 4-way audit system is unique and we are proud to deliver a trustworthy service for our worldwide pharmaceutical clients with the highest level of independence, complete absence of conflict of interest and best quality audit reports available.