Audit Lifecycle

Rephine expertise and organization allows to perform audits to your raw materials or services’ supplier with total trustworthiness, wherever they are located.

Based on several years of experience, Rephine’s methodology ensures total impartiality and confidentiality during the whole audit process.

Remote Audits

Remote audits could be a must in exceptional circumstances, but they must be performed assuring its trustworthiness.

When exceptional circumstances arise, the necessity to keep on qualifying the pharma suppliers, triggers innovation to look for alternative tools to continue auditing materials and services’ suppliers in pharmaceutical industry.

Rephine developed, optimized and successfully implemented a methodology to carry out remote audits. This was possible thanks to our experienced and skilled team of auditors, long-term knowledge and the use of trend-setting communication tools that allow for efficient document and facility review.

Why Rephine?

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Rephine performs on-site audits for raw materials and services’ suppliers for drug manufacturers. Rephine’s methodology covers whole auditing lifecycle, from audit organization up to CAPA follow-up.

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Auditors' team

Rephine’s strong qualification system and follow-up training programs assures maximum competence of our auditors, independently of their location. Rephine has available auditors teams in different European countries, North America, China, India, Japan, etc.

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Our trusted method

Rephine’s methodology, reference for third-party auditing bodies, has been recently reviewed to include remote audits’ execution, from which several improvements are also applied to face-to-face audits, as the reinforcement of a phase I for auditee information and documentation evaluation.

Technical knowledge

Rephine’s technical department assures harmonization and homogeneity of the different audits during the entire cycle, from preparation to revision of the outcome. Rephine applies a uniform criteria, aligned with Health Authorities requirements.
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Quality system

Our Quality System was developed to achieve full harmonization between our processes, staff, efficiency, technical criteria and GMP requirements. Our Quality System was accredited according to ISO 17020 in 2013.

Proven Methodology

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Our global and long-experienced auditors team, allows Rephine to perform remote audits looking for proximity and collaboration with the auditee, sharing language, time zone and knowledge about local industry.
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Our trusted method

Rephine’s methodology for remote audits consists of two phases:

#1 Information:
Exchange of information and documentation with auditee.
Information evaluation and challenging. Focus of approach and objectives for second phase.

#2 Telematic meeting:
Assessment of consistency of all information obtained. On-line inspection of facilities, records, electronic data, etc.

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Audits’ background

Thanks to our long- term presence in the business, many of the auditees have already been inspected before (some of them on many occasions) by Rephine. This is an essential part within the first phase of Rephine’s methodology, which together with the public information, which is collected and evaluated, allows us to have more detailed information about them prior to the audit.
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Trustworthiness evaluation

Once the audit exercise is executed, its trustworthiness is determined through a risk assessment.

It identifies the main findings of the audit, the recommended period of validity of the report and the ongoing actions to be taken.

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.

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