Environmental monitoring

To ensure the absence of previously manufactured pharmaceutical products from your production equipment, we use suitable analytical techniques. QACS Laboratory quality assurance approach starts from the preparation of a suitable protocol to the qualification of analytical results.

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

We undertake the protocol compilation, sampling, testing and reporting. Using Molecular biology tools-DNA Microlab, we provide the advantage of rapid, accurate microorganism identification. Environmental monitoring services have been implemented in a variety of classified GMP compliant manufacturing areas.

Cleaning validation is important in the pharmaceutical industry. We have developed and implement a microbiological method validation protocol, to document method suitability.

We use high-performance liquid chromatography (HPLC) to ensure that the routine cleaning process you perform on your manufacturing equipment removes all residues of the previously manufactured product. In HPLC assay verification, we validate linearity, intermediate precision, recovery and specificity. Some of the equipment we test include the preparation and storage tanks, the filling nozzles and the instruments.

 

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