Pharmassess Audit Reports
Marketing Authorisation Holders (MAH) are required to audit their suppliers at least every 3 years to ensure that manufacturing processes comply with Good Manufacturing Practice (GMP).
These audits can be carried out by the MAH themselves or someone acting on their behalf. A more economical and efficient way of satisfying this regulation is by the purchase of the report of a GMP audit that has been undertaken by a reputable organisation and a full report has been written which satisfies QPs and regulatory authorities.
Rephine has a large library of such reports of GMP audits of pharmaceutical manufacturers, named “Pharmassess” reports and these are available to customers of the relevant suppliers. The reports are detailed and comprehensive, always containing the name and address of the site, the dates of audit, the CV of the auditors, and the list of products covered by the report. The Pharmassess reports can be purchased from Rephine, subject to the permission of the supplier, and will be dispatched within a few days.
Info: g.santolero@rephine.com
Rephine Ltd – Stevenage – SG1 2EF – UK
T: 0044-1763.853135 M: 0039-324.05.06.888
Rephine GMP Auditing
Founded in 1998, Rephine is a UK based pharmaceutical consultancy specialising in GMP Auditing Service, including APIs (to ICH Q7 and Q9 standards), intermediate products, excipients, and packaging audits. As a result of its experience and expertise, Rephine is a leader in third party GMP audits, having carried out hundreds of audits worldwide.
Rephine offers a comprehensive, fully independent, third party GMP auditing service producing comprehensive high quality audit reports more economically than manufacturers undertaking the audits themselves.
Rephine only uses auditors who are highly experienced and qualified, and many of the auditors are QPs. Audits are fully independent and reports are detailed and comprehensive which fully address all client specific needs.
As part of the audit report, clients receive a schedule of corrective actions to be undertaken, updates as indicated by the findings of the audit and a final close out document, confirming that all corrective actions have been completed.
Rephine audit reports have been accepted by QPs and Regulatory Authorities in over 30 countries including the MHRA and EMA.
Info: g.santolero@rephine.com
Rephine Ltd – Stevenage – SG1 2EF – UK
T: 0044-1763.853135 M: 0039-324.05.06.888
Rephine Regulatory Services
Rephine provides regulatory services to pharmaceutical companies, either as support to internal staff or as a turnkey solution. Rephine’s regulatory work is worldwide and Rephine is up to date with international legislation, guidelines and customer practices in all relevant countries.
Regulatory activities undertaken include making submissions to regulatory authorities for marketing authorisations and applications for quality certification, as well as collecting, collating and evaluating appropriate scientific data for such submissions.
Where required, Rephine can support submissions by planning and developing product trials and interpreting trial data, alongside writing documentation and explanations for new product licences and licence renewals.
Writing clear, accessible product labels and patient information leaflets is an international requirement and Rephine has the necessary expertise to undertake this.
Rephine will liaise with, and make presentations to, regulatory authorities for marketing authorisations, including undertaking and managing regulatory inspections.
Info: g.santolero@rephine.com
Rephine Ltd – Stevenage – SG1 2EF – UK
T: 0044-1763.853135 M: 0039-324.05.06.888