Third Party Audits

We are aware of the needs and expectations of pharmaceutical companies and of the auditing pressure their suppliers undergo. This led us to create a model that provides advantages to all parts delivering a high-end audit service.

The Audit Process

We look for the best audit organization, avoiding time and efforts dealing with all the stakeholders to schedule the audits according to the sponsors’ deadlines and according the auditees’ schedule.

Once the audit is contracted by the audit sponsors, we initiate our process, setting up the audit days – according the auditee schedule and sponsors’ deadlines. Once the audit is arranged, we look for the best qualified auditor team  a Qualified auditors to best address the audit.

We take care of the entire audit lifecycle: audit preparation, execution, reporting and CAPA follow-up to allow you crossing out the audits to your suppliers from your list.

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Why Choose Rephine?

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Confidentiality

All information handled is strictly kept under confidential terms, including NDA or CDAs, from sponsors participating in the audit to the auditee information delivered to the audit sponsors through the personalized reports.

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Impartiality

Auditors apply impartial criteria when performing the audits, assessing the sponsors’ specific requirements, and addressing them to the auditee.

No Conflict of Interest Audits Icon

No Conflict of Interest

EMA recommendations about absence of commercial relationship between auditee and auditor are reviewed during the auditor’s allocation process.

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Personalised Reports

Each sponsor receive a complete report with the information related to the products of their interest and the inclusion of the revision of their specific requirements.

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Global Coverage

With local auditors all around the globe, we can perform and deliver audits to any country.

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Audit Scope

API, Medical Devices, Distributors, GCPs, Packaging, Excipients, Carrier and Software

Shared Audits

We take advantage of our great experience and look for the most convenient solution to offer you the best price.

 
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AUDIT STEPS

Audit Request Pool of customers > look for other sponsors interested > Share the cost Set up contract and agreements with audit sponsors
Audit request
Schedule the audit with auditee Auditor team allocation Audit preparation
Audit Preparation
Audit performance Revision of audit report Personalized reports sent to audit sponsors
Audit Performance and Reporting
CAPA Follow-up AFA remind of expiry dates to arrange follow-up audits
Audit Follow-up
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Where do you Need our Help?

For GMP Auditing, Quality Assurance & Regulatory Compliance, we’re the partner of choice for all the stakeholders we deal with.

We provide extensive GMP consulting and regulatory services to help keep our clients ahead of the needs and expectations of regulators.

Browse Audit Library

GMP Audit Services

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GxP Consultancy

GxP Consultancy

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Global Audit Library

Global Audit Library

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Regulatory

Regulatory

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Let's get in touch

Please get in touch. Our expert GMP audit team is only a click away, on standby to answer all your questions.
Email: [email protected]
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Telephone:

Rephine HQ, UK
+44 1763 853135

Barcelona, Spain                               +34 934 178065











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