The Quality Control Laboratory and the Quality Assurance department of Laboratórios Atral allow a global approach to quality requirements while maintaining a focus on customer commitment.
The quality control department of Laboratórios Atral has an experienced team of qualified technicians able to ensure the performance of the different analytical tests in both the raw materials, the packaging materials and the finished product (release and stabilities) in order to ensure compliance with their approved specifications.
According to the ICH directives, in this sector we have climatic chambers with continuous monitoring of temperature and humidity, which allows the preparation of stability studies for all climatic zones.
This functional unit also ensures the activities of validation of manufacturing processes, cleaning validation, validation of analytical methods and other studies required for regulatory compliance.
The various analytical technologies available in our laboratories allow us to meet the most demanding needs for this sector of activity:
- Physical-chemical tests
- (Ex: Spectrometry with absorption by UV / Vis, IV and NIR, HPLC and GC chromatography, Potentiometric titrations, TOC, Physical and chemical tests).
- Pharmacological Testing
- (Ex: Dissolution, disintegration, hardness and friability tests, particle counting in solutions, viscosity, …)
- Microbiological Testing
- (Eg Bacterial Endotoxins tests; Microbiological control of products not necessarily sterile; Identification of strains; Qualification of disinfectants; Environmental control and water control; Development and validation of microbiological methods; Levels of microbial contamination and microbiological substances).
