Pharmaceutical Analysis
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Monday, November 10 2008
By Denis Vignes on Monday, November 10 2008, 15:21
- Full GLP compliance (AFSSAPS, AFSSA, COFRAC)
- Full GMP compliance (authorization Nos. M07/258, AFSSAPS and V2578/07, AFSSA, FDA registration No. 3006118993)
- Compliance with ICH and VICH guidelines
- Review of protocols / raw data / reports
- Critical phase inspections
- 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, 15:08
- HPLC systems (UV, DAD, RI, conductivity and fluorescence detection)
- GC-FID, GC-MS (EI, CI) GC - HeadSpace injectors
- UV/IR spectrophotometers, potentiometer, KF, polarimeter, densimeter, rheometer
- Dissolution testing systems with automatic sampling and on-line UV detection
- Equipment for disintegration, friability and hardness tests
- Osmolality, particle counting and microscopy
- Stability chambers (in compliance with ICH and VICH guidelines, over 45 m³ of storage)
- 25°C / 60% RH
- 30°C / 65% RH and 30°C / 75% RH
- 40°C / 75% RH
- 25°C / 60% RH for photostability studies
- 5°C and - 20°C
- Other conditions available on request
By Denis Vignes on Monday, November 10 2008, 14:55
GLP analysis of dosage forms used for toxicology studies
- Development and validation of analytical methods
- GLP analysis of dosage forms used for toxicological and safety pharmacology studies
Analytical development and support for formulation development
- Development, pre-validation and robustness of analytical methods
- Forced degradation and pre-stability studies
- API/excipient compatibility
- Analytical support for formulation development and process robustness
- Establishment of monographs for NCEs and herbal drugs
Validation and Transfer
- Validation of analytical methods
- Analysis for cleaning and process validation
- Design and interpretation of analytical method transfers and robustness studies
- Experimental design (DOE) and statistical interpretation
Stability studies
- Stability studies on drug substances and finished products (including clinical batches)
- On-going stability studies
- In-use stability studies, cyclic temperature stress studies, photostability
- Extractables/Leachables studies (packaging)
Micellaneous
- Identification of impurities by GC/MS or LC/MS/MS
- Assay of genotoxic impurities (according to CPMP/SWP/5199/02)
