Environmental Monitoring Testing services, cleaning validation studies, gmp testing services, cleaning validation analysis, gmp compliant lab, cleaning validation testing

To ensure the absence of previously manufactured pharmaceutical materials & impurities from production equipment, QACS Labs use suitable analytical techniques. The laboratory’s quality assurance approach begins with the preparation of a suitable protocol and ends to the qualification of analytical results.

Environmental Monitoring

In compliance with the current GMP Annex 1, QACS laboratory offers Environmental Monitoring services for GMP manufacturing areas. We specialize in the preparation and implementation of the manufacturing area  through Environmental Monitoring programs involving air and surface sampling.

We undertake protocol compilation, sampling, testing and reporting using Molecular biology tools-DNA Microlab,  QACS Labs provide the advantage of rapid, accurate microorganism identification.

 

Cleaning Validation

High-performance liquid chromatography (HPLC) is used to ensure that a routine cleaning process performed on manufacturing equipment removes all residues of previously manufactured products. In HPLC assay verification, we validate linearity, intermediate precision, recovery and specificity. Cleaning validation for manufacturing equipment includes testing of preparations & storage of tanks, filling nozzles and instruments.

QACS Labs develop and implement microbiological method validation protocols, to document method suitability.

For Environmental monitoring and validation services contact us – info@qacs.gr – 30 210 29 34745