To ensure the absence of previously manufactured pharmaceutical materials & impurities from production equipment, the GMP certified QACS Lab uses 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.
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 studies
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 perform cleaning validation testing by developing and implementing microbiological method validation protocols, to document method suitability.