The Gold Standard in Life Sciences Product & Device Quality

Global experts in quality assurance & GxP compliance across pharmaceutical, biotech & medical device manufacturing supply chain

Strengthen Your Assurance Journey

GMP Chapter 22 Adapting to Hybrid Documentation Standards

GMP Audit Services

We are deeply experienced GxP consultants,  auditors and practitioners. We’ve been proactively helping pharmaceutical and medical device companies around the world with these supply-chain quality assurance services for over 25 years.

GxP Consultancy

Our GxP readiness services assess and target improvements across all manufacturing systems and processes, ensuring there are no gaps in quality or compliance, in any phases of the product development and manufacturing lifecycle.

Global Audit Library

We assess and report on a whole range of manufacturing sites and product lines, producing off-the-shelf reports available for purchase. In fact, we offer the single largest repository of live reports (within three-year validity), spanning thousands of individual products.

Welcome to Rephine

Once a manufacturer has been ‘Rephined’, quality is assured.

We are product quality experts, serving the strictly regulated life sciences industry – encompassing pharmaceutical, biotech and medical device manufacturing supply chains globally. Our services extend right across the product development lifecycle – from raw materials/device components to patient delivery.

Highlighted offerings include:-

  • GxP readiness services
  • Digital transformation of manufacturing controls, including robotic capabilities
  • Quality Management System advisory service
  • Tailored services for the Medical Device market
  • Auditing services & reports including on-demand audits and re-validated off-the-shelf audit reports

With our honed processes, bespoke service design, appropriate use of technology, and audit report consistency, we have established an enviable reputation and are widely acknowledged to be the Gold Standard in our field.

Global Audit Library

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Search our Audit Library

Simply skip straight to a search to locate the reports covering the sites and products you require
 

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Browse the Audit Library

Browse our global GMP audit library to see the range and scope of live reports we have in stock

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Join an Audit in Progress

Specify your unique requirements for inclusion in an upcoming inspection and report, optimise the efficiency and cost control of your supplier auditing

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Commission a Bespoke Audit

For tailored needs, we conduct rigorous on-demand custom audits of pharma manufacturers globally

Ensuring Compliance and Data Integrity in Pharmacovigilan CAPA

Strengthening CAPA & Exceptions Management

Learn how Rephine’s tailored GxP training helped a pharmaceutical manufacturer strengthen CAPA effectiveness, improve compliance, and boost team confidence.
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GMP Raising the bar Blog series Header image May 25 Blog

EU GMP Annex 1 vs FDA Aseptic Guide: Bridging Compliance

EU and U.S. regulators share the same sterility assurance goals, but their approaches differ. Learn how to align Annex 1 and FDA guidance to streamline ...
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Ensuring Compliance and Data Integrity in Pharmacovigilan Case Study

QMS Implementation for Cannabis Manufacturer

Discover how Rephine helped a new cannabis API manufacturer design and implement a compliant QMS, enabling GMP authorisation and audit readiness.
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GMP Raising the bar Blog series Header image May 25 Blog

GMP & GDP: Ensuring Quality in Drug Storage and Transport

Storage and transport aren’t just logistics — they’re critical GMP processes. Discover how USP helps pharma companies manage risk and maintain quality across global ...
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Rephine partners with Scilife to deliver stronger digital quality and compliance solutions Company News

Rephine Partners with Scilife to Strengthen Digital Quality and Compliance Solutions

Rephine has announced a new partnership with Scilife, a leading Smart Quality Management platform provider. By joining forces, the two companies will deliver stronger compliance ...
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GMP Raising the bar Blog series Header image May 25 Blog

Blockchain for GMP Documentation: Hype or Future Reality?

Blockchain promises immutability, traceability, and transparency for GMP documentation. But is it a compliance game-changer — or just hype?
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Medical Device Guide

Is Your Insurance Policy Ready for the New EU Product Liability Directive?

The EU’s new Product Liability Directive (2024/2853) changes who can be held liable and what damages can be claimed. From software and data loss to ...
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News update: 100% drug tariffs in the USA impacting pharmaceutical supply chains and compliance Article

100% Drug Tariffs in the U.S. – Impact on Pharma Supply Chains & Compliance

The U.S. has announced sweeping 100% tariffs on patented medicines, disrupting pharma supply chains and market access. Discover what this means for manufacturers — and ...
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CSV Blog

Data Governance & AI in Pharma | Ensuring Trust & Compliance

In an age where AI promises transformation across pharma, success hinges on one factor: data you can trust. Explore how rigorous governance, quality control, and ...
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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

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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REPHINE HQ

REPHINE BARCELONA S.L.U

  • Barcelona, Spain                               
  • +34 934 178065

REPHINE CHINA

  • Shanghai, China 

REPHINE INDIA

  • Hyderabad, India                               

Contact Us

Strengthen Your Assurance Journey

GMP Chapter 22 Adapting to Hybrid Documentation Standards