5m Partner’s quality audits
5m Partner propose aux industries de la santé, de la beauté et à leurs fournisseurs et prestataires des audits qualité sur-mesure.
Industriels de la santé et de la beauté, en France, en Europe et dans le reste du monde, confiez-nous vos audits qualité :
- Medicines,
- Pharmaceutical raw materials (API/active substances, excipients, intermediates…),
- OTC,
- Cosmetics,
- Medical devices,
- But also, food supplements,
- and suppliers and service providers (storage, transport, cleaning…).
Our quality audits are carried out according to the standards applicable to your products:
- BPF européennes et US GMP (21CFR 210, 211, 600, 640, part 4…),
- GDP,
- Guidelines ICH,
- Guides IPEC et ligne directrice européenne Excipients,
- OECD GLP,
- ISO 13485 et 21CFR 820,
- ISO 22716, CSAR et MoCRA,
- ISO 15378,
- Directive européenne, ISO 22000, Charte qualité Synadiet et 21CFR 111 et 117…
5m Partner, customized quality audit services
Our quality audits are systematically carried out in compliance with the ISO 19011 standard, by expert auditors internally qualified according to the 5m Partner qualification process. 5m Partner.
The technical and regulatory expertise of our senior consultants guarantees you:
Our work method
We can help you with your quality audits :
At your request and according to your needs, we carry out:
- Gap analysis to assess the compliance of your Quality Management System with new applicable standards or changing quality requirements,
- Technical quality audits to assess the compliance of an installation/equipment/room/workshop/technical process,
- Audits of your Quality Management System or that of your suppliers/services providers/subcontractors on a "one to one" basis (1 single contract giver for 1 supplier audit carried out) or on a shared/mutualized basis (several contract givers for 1 supplier audit carried out).
We operate:
- To support your quality auditors’ teams:
- When subcontracting audits,
- As a technical expert on a specific equipment or standard.
- In building or optimizing your quality audit tools:
- Risk analysis for the construction of your periodic audit program/schedule,
- Construction of standard audit matrices/ questionnaires,
- Optimization of your report template…
We also offer you:
- Preparation or assessment of the post-audit remediation action plan,
- Webinar presentation of findings,
- Support in the deployment of the quality remediation action plan,
- Training and support for:
- Your future quality auditors to the methodology and techniques of quality auditing,
- Your teams to the regulatory changes applicable to your activities and projects.
Check out our other areas of expertise
