GMP Audit Services

Life sciences manufacturing supplier qualification and supply chain
GMP auditing is probably the capability we are best known for.

We’ve been providing these services for over 25 years, and are known for our high levels of consistency and for applying the highest standards of rigour.

Auditing Services

Whatever your supply-chain inspection needs, we’ve got you covered.

We have been auditing pharma manufacturers for more than 25 years. With our honed processes, attention to detail, and report consistency, we are widely acknowledged to be the Gold Standard in our field. Rephine performs various GMP audits including Active Pharmaceutical Ingredients (APIs) and Intermediates to ICH Q7 and ICH Q9 standards, as well as excipient, packaging and various other audits.

Why choose Rephine?

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Quality

Comprehensive, high quality, customised, and fully independent reports.

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Confidentiality

Your information managed securely is an integral part of our process.

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Compliance

Reports accepted
by Regulatory, Health, and
Compliance Authorities.

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Time

Reports delivered and live
in days through the Rephine
Audit Library.

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Expertise

Carried out by specialised, highly experienced
and qualified auditors.

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Coverage

Designed specifically to cover whole sites; including QMS, facilities, and resources.

We take pride in our Global Audit Library achievements

We offer the single largest repository of reports within three year validity, spanning more than 2,500 individual products, so whatever you’re looking for there’s a good chance we’ve already got it covered.

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Product Audit Reports
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Audits conducted over 25+ years
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Customers
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Quality Satisfaction

Discover our suite of GMP Audit Services

Third Party Audits

We conduct rigorous audits of pharma manufacturers across the supply chain, to ensure strict GMP standards are being fulfilled for applicable regulations and ensuring patient safety.

Audit Lifecycle

Rephine’s methodology guarantees all information is handled with impartiality and confidentiality. These values are key in maintaining
the credibility during the whole audit process.

Auditee Support

Reduce your audit burden with our comprehensive Auditee support service, we aim to free up Auditee internal resource for efficient and effective audits all whilst reducing costs and streamlined CAPA management.

business man financial inspector and secretary making report, ca

Regulatory Services

Our deeply-experienced Regulatory experts can provide help right
across the regulatory lifecycle, to ensure that dossiers are ready for market delivery and maintain ongoing compliance submission.

If you'd like to find out more about our GMP Audit Services and how we can help with your QA requirements

Get in touch with us today to arrange a free 30 minute consultation with our experts

Helping you reach more buyers

An exclusive partnership with Pharmaoffer

Rephine are the only featured GMP Audit service provider on the leading online search comparison platform for global API and GMP pharma suppliers

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Where do you Need our Help?

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

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

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Global Audit Library

Explore our extensive GMP audit library to see the range and scope of live reports we have in stock, join a live audit, or commission a bespoke audit

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GMP Audit Services

Maintain high standards of life sciences manufacturing supplier qualifications and GMP auditing within the supply chain through our expertise

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GxP Consultancy

Discover how we can help your product reach to market, fully and demonstrably complying with the latest GxP standards

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Digitalisation

From data integrity to implementing new systems, our experienced team with a digital mindset, can lead you to transformative achievements

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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.
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