Pharmaceutical Quality

Our approach :

  • High level of quality through continuous sharing of practices
  • Common Quality System for all GMP / CAPA / CC documentation
  • Regular audits by our customers and the health authorities of the countries

A visible quality commitment

Each site has its own control laboratory, with proven technologies such as HPLC, CPG, SAA as well as Ion Chromatography.
More than a simple Pharmacopoeia control, we qualify the active ingredients and raw materials from a rheological point of view.

Standards & Accreditations

Galien® has successfully validated the following international MOH inspections and certifications:

ANSM (French MOH) Russian Authorities TÜV Rheinland – ISO 13485* Kuwait
GCC-DR Turkish Authorities US FDA** ANVISA**
UAE Lebanon

*Approval for Medical Device
**In progress

ISO 50001: 2018

The management system implemented on the Galien LPS Nevers site for the manufacturing and packaging activities of pharmaceutical products is certified in accordance with the requirements of ISO 50001: 2018

*COFRAC accreditation n ° 4-0001, Management System Certification, scope available on www.cofrac.frAFAQ is a registered trademark.

By developing methodical energy management (Water, Gas, Electricity), this standard aims to improve our Energy Performance.

Our goal is to bring this ISO 50001 approach to all of our sites.

Supply Chain Management

Because we consider that our service is only finished when your product is available for marketing, Galien® has built a robust operational structure:

  • A Sales Administration Service, which ensures the follow-up of each order with a privileged interlocutor for each customer
  • A Scheduling Planning Service, which manages operations and aims to meet the requirements of customer deadlines
  • A Logistics Service, which manages the stocks of all components and finished products, and which can also be responsible for the charter of finished products

We have implemented OTIF performance indicators to monitor our services, and continuous improvement programs based on the analysis of these indicators.

Industry 4.0

New technologies are now an full part of traditional industries, to optimize each stage of production, to predict breakdowns, to generate relevant decision-making information, or to better protect women and men.

To increase the quality of the manufacturing processes and the products delivered, we are investing in the integration of software intelligence within the production apparatus, the Industrial IoT, and the implementation of innovative systems:

  • Thermal enhancers, semi-robotic warehouse, connected freezers, digital document processes, automated real-time analysis of line performance, etc.

Thanks to these technologies and processes at the heart of the Company, we provide exclusive products and services with high added value.

Health Safety Environment

The Galien® sites undertake to do everything possible to limit their impact on the natural environment by relying on an efficient manufacturing system accompanied by a regular review of the indicators (water, waste, energy consumption, etc.).

In this spirit, Galien® takes responsibility for its acts of production:

  • Own production techniques
  • Waste reprocessing + Wastewater treatment
  • Economy of natural resources
  • Protection of employees: clothing, emergency procedures, Risk management

In line with sustainable development, we initiate with our partners:

  • Verification and development of waste recycling programs
  • Upgrading of technical equipment and non-recyclable waste