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.
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 goal is now to produce 4 PHMB pharmaceutical excipient grades on our industrial site and obtain our GMP production authorisation by Q2 2024. This GMP authorisation delivered by the French authority will be based on a quality system that responds to EU Guideline of 19 March 2015 at least § 2.6 (2015/C 95/02).
Subsequently, we will seek to obtain an EXCiPACT cGMP certification based on a quality system IPEC/PQG GMP&GDP.
Finally, once we have achieved, these 2 crucial stages, we will aim higher to obtain a GMP Part II certification for our PHMB as an API.
We will be proposed our 4 PHMB pharmaceutical grades as we go along:
In Q2 2024
- 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