Certifications and classification
PHMB Pharma grades – ISO 9001
As a manufacturer of a substance classified as “toxic for the aquatic environment”, our production site is classified SEVESO (low threshold) according to European Directive. Our production site is thus, subject to authorization of exploitation granted by local governing authority.
ISO 9001 CERTIFICATION
Laboratoire PAREVA’s processes are certified ISO 9001:2015 since 2020.
The ISO 9001 certification applies to our main activities: sales & marketing, production & logistics, regulations & Health, Safety and Environmental Plan as well as Human Resources & Administration.
The scope of our Quality Management System concerns our production site in France. This Quality Management System ensures that customers consistently receive quality products and services.
We place this ISO 9001 certification at the core of our business values as it drives us to continuously improve our processes and product quality to conform to best standards.
Pharmaceutical grades and GMP certification (on-going project)
Laboratoire PAREVA’s processes are certified ISO 9001:2015 since 2020 and our short term goal is to produce a PHMB pharmaceutical excipient grade on our industrial site and obtain our GMP production authorisation in 2024. This GMP authorisation will be delivered by the French authority and based on a quality system that responds to EU Guideline of 19 March 2015 at least § 2.6 (2015/C 95/02). Subsequently, in 2025, we will seek to obtain an EXCiPACT cGMP certification based on a quality system IPEC/PQG GMP&GDP.
Our medium-term goal (2026), is, ultimately, to manufacture a PHMB pharmaceutical grade to be used as a drug substance or API (Active Pharmaceutical Ingredient) based on a GMP Part II quality system.
We will propose 4 Quality Systems for our PHMB pharmaceutical grades :
- PHMB P20 Pharma excipient grade / ISO 9001
- PHMB P20 Pharma excipient grade / EU Guideline of 19 March 2015 at least § 2.6 (2015/C 95/02)
- PHMB P20 Pharma excipient grade / IPEC/PQG GMP&GDP
- PHMB P20 Pharma grade / GMP Part II