Aiming at first-class quality control for the manufacture of the client’s or our own products a pool of bio-analytical expertise and excellence has evolved over the years. Translating scientific concepts into valid routine assays is the core theme in this area.
Similar to process development for product manufacturing, the generation of a qualified and validated assay is accompanied by many obstacles that had never been an issue for scientists in a non-GMP/GCLP laboratory, but become critical once the assay is used for collection of data concerning efficacy or quality of active biopharmaceutical ingredients (bio APIs).
Glycotope’s know-how in this field reflects a proven track record in bio-analytical method development, qualification, validation and routine application. Facilities and all instrumentation is qualified in compliance to good control laboratory practice, GCLP. The results of the analysis and our reports are accepted by regulatory authorities worldwide. The established quality system follows the principles:
- well-trained personnel
- traceable receiving, storage and analysis of samples
- use of controlled and traceable materials
- qualified analytical procedures accompanied by product specific validation
- qualified, calibrated equipment and instrumentation
- adequate procedure documentation, protocols and reports
- change control system and quality risk management
- document archiving as required
Our quality system ensures that all analyses are fully and transparently performed from the planning stage, the execution of the study itself, through to the reporting of the results. Glycotope offers a comprehensive validation programme in accordance to the ICH Q2A (R) guideline. The validation data can be reviewed at our facility in the context of a client audit. In order to guarantee a constantly high quality standard, our QA system is regularly audited.