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Because quality matters – Your audit and QA resource

Rephine is devoted to quality “because quality matters”. Encompassing experience in the areas of GMP, GCP, GLP and GDP, with experts and trainers around the world, Rephine provides a consultancy service ranging from advice to the performance of complex QA procedures. Rephine currently has over 25 auditors around the world and its activities can be tailored to its clients’ specific needs. Due diligence, crisis avoidance and the review of API sourcing, as well as training and QP services, are an integral part of its activities. Rephine services the global healthcare industry and has the largest library on GMP audits worldwide, references to which can be found on its website. Rephine has collaborated with a number of manufacturers on the five continents and with its background in FDA and EU requirements, can support companies in the achievement of those standards of good manufacturing practice.

Frequently Asked Questions

A GMP audit is a very important regulatory process. Pharmaceutical manufacturers are required to perform GMP audits of their suppliers or have these conductedon their behalf. Rephine provides GMP audits and services worldwide meeting all standard regulatory requirements. Please visit the website for a list of the most recent facilities audited.

Rephine is specialised in GCP audits performed in all fivecontinents as well as consultancy and advice in any GCP-related matters. Our auditors are also aware of the relevance of being respectful of cultural differences and attitudes, while assuring the fulfilment of GCP regulations.

RephineSourcing.com is a unique system specifically designed for API marketing and documentation management. This system provides customers with instant access to QA data on APIs, making the sales process straightforward and efficient. This innovative service can save a lot of and resources for your company, streamlining the selection of API producers.

Rephine has a library of GMP audit reports ready and available that can be provided to customers. Audit reports in the library are comprehensive and satisfy all QPs and regulatory authorities and cover the entire manufacturing site, meaning that all products are covered by the report. The report allows customers to receive an immediate independent statement on the GMP compliance of their suppliers and fulfil all necessary regulatory requirements. Visit our updated list of audit reports.

Supporting the research and development of medicinal products, Rephine provides a comprehensive portfolio of GxP services, such as:

  • Consultancy: CRO/Vendor Selection, Audit Programme Development, QMS Development etc.
  • GxP Training and Coaching (GLP, GCP, GCLP, GVP etc.)
  • Clinical Research and Clinical Project Management Training
  • Facility Audits (Clinical Unit, Laboratory, IMP Depot, Archiving Facility etc.)
  • Vendor Audits (CRO, IT Solution Vendor, CTSL Vendor, PV Vendor etc.)
  • System Audits (CSV, QMS, Data Management, Records Management etc.)
  • Project Audits (BA/BE, Phase I-IV, (e)TMF, Clinical Database etc.)
  • BA/BE Study Management and Monitoring
  • GxP Inspection Preparation (Audits and Mock Inspections)
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