Quality isn’t a promise—it’s how we operate
Every operation carried out at Cosmépharm engages our clients’ regulatory responsibility. Our quality system exists to demonstrate it, not just to promise it.
An audit-ready site, at all times
Cosmépharm operates within a regulated pharmaceutical and cosmetics environment. Our organisation is structured to demonstrate our risk management capabilities at all times — whether during a client audit, an ANSM inspection or a visit from the regulatory authorities.
Our quality management system covers all our activities: from secondary packaging to serialisation, and from repackaging to quality control.
« We don’t sell compliance. We live it every day—every batch, every line, every operator. »
Fabrice Gonin — Interim Responsible PharmacistDes référentiels qui parlent aux experts
Good Manufacturing Practices
Mandatory standard for all pharmaceutical manufacturing and packaging activities. Ensures compliance of pharmaceutical operations.
ISO 22716
International standard for Good Manufacturing Practices applied to cosmetic products. Covers production, control, storage, and shipment.
ISO 13485
Quality management system for medical devices. Regulatory requirements for design, development, and production.
SYNADIET
French National Association for Food Supplements and Health Foods. Membership ensures compliance with good manufacturing and labeling practices.
CCS
Additional certification confirming that the quality management system complies with the specific requirements of pharmaceutical packaging.
Quality Manual & Management Review
Internal document structuring the entire Cosmépharm quality system. Reviewed annually during management review.
Each process is documented, auditable, and traceable
Our quality system is based on proven processes, aligned with ICH Q9 and ICH Q10 guidelines, and audited both internally and externally.
Document management — QMS § ICH Q10
All our quality documentation is structured, version-controlled, and accessible. Procedures, SOPs, work instructions, and written records.
Dual verification of critical process steps
Each step identified as critical is subject to dual verification by trained and qualified operators.
Batch segregation — Cross Contamination § ICH Q9
Cross-contamination prevention strategy based on physical and temporal separation of batches.
Audit trail & data integrity
Full traceability of production data. Compliance with ALCOA+ principles for data integrity.
Deviation management & CAPA
Structured system for detecting, investigating, and correcting deviations. Documented and monitored corrective and preventive actions.
Training & qualification
Each employee is trained in GMP, specific procedures, and equipment. Qualifications are tracked and regularly renewed.
Internal audits
Scheduled internal audit program covering all processes. Continuous readiness for client and regulatory inspections.
Client & regulatory inspections hosting
Structured organization to host client audits and inspections by competent authorities (ANSM, QHSE auditors).
Downloadable documents
GMP Certificate
Certificate of compliance with Good Manufacturing Practices
PDF — 744 KBISO 22716 Certificate
Cosmetic certification — latest audit 2025
PDFISO 13485 Certificate
Medical device quality system
PDFSYNADIET Certificate
Membership and compliance for food supplements
PDFQuality policy
Cosmépharm’s quality commitments and strategic priorities
PDFGDPR policy
General Data Protection Regulation (GDPR) policy
PDFA regulatory guarantor leading quality
Quality & HSE Director
En tant que Pharmacien Responsable, Franck Chalet assure la conformité réglementaire de l'ensemble des opérations de Cosmépharm. Il est l'interlocuteur direct des autorités de santé et le garant de la qualité pharmaceutique des prestations réalisées.
Sa double casquette PR / Responsable Qualité HSE garantit une vision transversale de la qualité, de la sécurité et de l'environnement sur le site de Varennes-sur-Allier.
Need quality assurance for your project?
We can provide all the quality documentation required for your evaluation.