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