Diapharm’s 4-way audit system

30.08.2019 | Eimear Schulte

Eimear Schulte
Associate Director Global Audit Solutions

We at Diapharm have created the first 4-way audit system for auditing APIs with the highest level of independence, best quality audit reports and unique trustworthy service for our clients. The customers of API manufacturers are required to regularly audit and evaluate them. In the past years, the amount of requests for an audit at manufacturing sites has increased dramatically. While it is mandatory for customers to audit their suppliers of APIs and excipients, this can pose economic and logistical problems especially when there are numerous customers for the same products. Independent audits are a sensible and economic way out of this dilemma. Especially in the traditionally strongly regulated area of the pharmaceutical industry, objective audits, independent inspections and certifications are becoming increasingly important.

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.

How does Diapharm’s 4-way audit system work?

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.

The relevant criteria

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:

  • Maximum level of independence guaranteed due to four parties involved
  • Highest quality audit report by auditors of an ISO 17020 type A accredited auditing company
  • Neither commercial interest between the customer and auditee nor between the customer and the auditing company
  • Reduced workload for the companies requiring an audit and the auditee
  • Control over the distribution of the audit report – confidentiality guaranteed
  • Acceptance of authorities worldwide

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.




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