Simplifying the audit process for drug manufacturers

Laurianne Kandalaft, Global Senior Marketing Manager, Eurofins Healthcare Assurance, LaurianneKandalaft@eurofins.com

Drug manufacturers must comply with the stringent regulatory requirements of GxP in order to develop and provide safe drugs to the market. Compliance is determined through regular audits of suppliers. Over the past number of years, the amount of supplier audits has drastically grown due to increasingly stringent regulations, which has led to an added challenge for suppliers to host many audits and for audit sponsors who accrue higher costs.

To smoothen the supplier auditing process, Eurofins Healthcare Assurance, as a 3rd party GxP and quality assurance audit provider, proposes:

• Shared audits
• Access to an extensive audit report library

How shared audits can simplify

A shared audit is auditing one supplier site on behalf of several drug manufacturers. This means that the cost of the audit is shared by the manufacturers and that the audited supplier sites will have to host only one audit instead of several.

As a 3rd party audit provider, Eurofins Healthcare Assurance will take care of the whole audit organisation, which results in smooth audit scheduling and lower costs for manufacturers. It also lowers the burden for the audited sites to welcome auditors. Audits manufacturers’ names are kept confidential and are provided a final report that contains specific information about material of interest for each one of them.

Benefits of our audit report library

For drug manufacturers who require immediate access to an audit outcome and insights, existing audit reports are made available in our extensive library, which contains more than 700 reports, validated within the last three years or less. Every purchase request is treated with the highest level of confidentiality, and reports are only shared with the agreement of the audited site. Our unique report library is accessible here: www.eurofins.com/pharmasharedaudits.

Eurofins Healthcare Assurance experts have more than 20 years of experience in the healthcare industry and can support manufacturers with the highest level of quality, in a cost-effective and time efficient manner.