GxP audits for the pharma industry

Our expert auditors help you to ensure that you comply with international regulations & standards and stringent market requirements recognised in the pharmaceutical industry in order to bring safe drugs to the market.

We support drug manufacturers with global quality assurance and GXP auditing services as we work with an extensive network of auditors based all over the world.

Our offer is tailored to your needs with:

• Individual audits
• Share audits
• Shared audit reports

Pharma supplier individual audits

We help pharmaceutical manufacturers control their complex supply chains with quality assurance and GXP auditing (GMP, GLP, GDP, GVP and GDP for pharma manufacturing).

We carry out individual audits on supplier sites (starting material, API, excipients manufacturing) on behalf of one pharma manufacturer.

The audit process will be fully customised to the requirement of the customer.

Pharma supplier shared audits

We audit one site on behalf of several pharma manufacturers and lower the burden of the audit management process.

Advantage for the pharma manufacturers sponsoring the audit:

• the access to the audited supplier site is easier and faster,
• the price decreases with the number of involved pharma manufacturers,
• no or lower entrance fees to be paid by the pharma manufacturers who sponsor the audit.

Advantage for the audited pharma supplier site:

• less audit sessions to handle.

The list of past and planned shared audits is available here.

Purchase of existing pharma audit reports

Purchasing existing pharma supplier audit reports allows more drug manufacturers to obtain quality assurance on their suppliers manufacturing processes without rescheduling or redoing an audit.

Pharma supplier audit reports are sold to pharma manufacturers only with the agreement of the audited site.

Our existing pharma supplier audit reports list is available here.

The scope of Eurofins Healthcare Assurance auditing services covers:

Pharmaceutical manufacturing sites, Supply chain (pharma suppliers and CDMO) and distribution flows, based on regulatory, international or customer pharmaceutical standards.

• GMP (Good Manufacturing Practice): Finished Products, including new annex 1 from EU GMP, APIs and Excipients manufacturers, Starting Material Manufacturers, Packaging Materials, Contract Laboratories for Analytical Testing, Service Providers, IT, Sterilization, Maintenance, Validation, Housekeeping, Pest control…
• GLP (Good Laboratory Practice): Laboratories used to perform all non-clinical safety studies which are intended to support research permits or marketing authorizations;
• GCP (Good Clinical Practice): Contract Research Organization (CRO), Investigation Center, Data Center;
• Support for the mapping of your supply chain to increase your control on it and mitigate associated risks.

Distribution and post-market surveillance:

• GDP (Good Distribution Practice): Distribution centers, Warehousing, Transportation;
• GVP (Good Pharmacovigilance Practice): Service providers for Pharmacovigilance activities.

And also:

• GDPR
• ISO 9001
• The Global Retail and Manufacturer Alliance (GRMA)

Auditing activities are compliant with EU, US, Canadian, Australian, Brazilian and Japanese regulation.