Since 1998, the GMP Bratislava site, located in the Slovak Technical University campus, is dedicated to the chemical analysis of small molecules, and the services encompass:
- Method development and validation studies
- Optimizing and re-validation of analytical methods
- Raw material and finished product testing
- Stability studies ICH Q1A (R2), including long-term testing, accelerated testing, photostability, stress testing, and more. Custom conditions are also available.
- Content of impurities and related substances in pharmaceuticals products
- Packaging testing according to Ph. Eur. – PP,PE, PVC, rubber sealings, glass, etc.
- Extractables & leachables
- Water testing
- Cleaning validation
The laboratory provides analytical testing services according to state-of-the art pharmacopoeial methods (Český lékopis, Ph. Eur., et al), as well as customs method.
Accreditations/Certifications/Registrations:
- STN EN ISO/IEC 17025:2018
- GMP-compliant
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The GMP Piestany site is dedicated to microbiological activities for sterile and non-sterile products.
- Services encompass endotoxin testing, microbial identification, disinfectant efficacy studies, water testing, cleaning validation etc.
- Besides, this site benefits from storage capacities for stability studies under ICH conditions or custom conditions/climatic zone 3100.
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