Quality control
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Monday, November 10 2008
By Denis Vignes on Monday, November 10 2008, 17:45
- Full GLP compliance (AFSSAPS, AFSSA, COFRAC)
- Full GMP compliance (authorization Nos. M07/258, AFSSAPS and V2578/07, AFSSA, FDA registration No. 3006118993)
- Review of certificates of analysis
- Monitoring and maintenance of archives for materials and study documentation
- Internal quality assurance program
- ISO 14001 Certification (Environment Management System)
By Denis Vignes on Monday, November 10 2008, 17:43
- HPLC systems (UV, DAD, RI, Conductivity and Fluorescence detection)
- GC-FID and GC-MS (EI,CI) systems/HeadSpace injectors
- UV/IR spectrophotometers, fluorimeter, potentiometers, Karl Fischer, coulometric titrator, densitometer, polarimeter, rheometer, viscosimeters (Brookfield + capillary), refractometer, water activity, etc.
- Osmometer, particule counting and microscopy
- Dissolution testing systems with automatic sampling and on-line UV detection
- Equipment for disintegration, hardness and friability
By Denis Vignes on Monday, November 10 2008, 15:26
Analytical release testing including QP certification
Products
- Raw materials (active pharmaceutical ingredients and excipients)
- Bulk and intermediate products
- Products under development
- Clinical batches
- Finished products
- Cosmetic products, herbal drugs and extracts
Physico-chemical testing
- Physical and physico-chemical analyses (pH, density, optical rotation, viscosity, melting point, Karl Fischer, coulometric titration, TLC, water activity,etc.)
- Analytical assays – potentiometric titration, HPLC, GC (active pharmaceutical ingredients, preservatives and impurities)
- Limit tests (sulphated ash, heavy metals, etc.)
- Identification and control of residual solvents – GC Headspace
- Pharmaceutical technical tests (friability, hardness, disintegration and dissolution)
In partnership
- Microbiological testing
- Assay by ICP/MS(more than 50 elements: metals etc.)
- Polymorphism analysis: DSC, TGA, X-ray diffraction, etc.
- Laser granulometry (particule size distribution, etc.)
