Environmental Monitoring services
To ensure the absence of previously manufactured pharmaceutical materials & impurities from production equipment, the GMP certified QACS Lab performs pharmaceutical testing services using 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.
Cleaning Validation studies ensure that a routine cleaning process performed on manufacturing equipment removes all residues of previously manufactured products. At QACS 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.
Using Metagenomics we study the genetic material of microorganisms in a given environment to provide valuable insights for quality control and safety in all industries.
Primary goal of Environmental Monitoring and MMS is to help brands maintain high-quality standards in their pharmaceutical production processes by closely monitoring & understanding the microbial populations within their facilities. We combine long-standing microbiology experience of plant areas with the power of NGS and Metagenomic Mapping to accurately:
- Map and monitor the complete microbiome of your production facility.
- Pinpoint pathogens and contaminants in the environment.
- Identify their routes and biofilms.
- Track their sources proactively.
- Gain full insight of the microbial populations in your production before it affects your products.
- Use the data retrospectively to identify possible sources of contamination in case of QC failure.
Untargeted approach: You only find what you are looking for! The presence of bacteria in production environments poses a constant threat to QA/QC managers who might face a huge challenge concerning recalls. The classical approach with swabs and culture plates only detects a limited number of microorganisms and often results are difficult or even meaningless to interpret.
Microbial Mapping from QACS Lab gives an untargeted approach to this procedure revealing the full picture:
- Samples are taken from all important sources in the production environment.
- Total DNA is isolated from all samples and sequenced with NGS.
- The full depth of the microbiome of each sample is revealed from each sample analysis.
- Combining the results of each sample a full microbiome map of the production environment is revealed.
- Metadata analysis, heatmaps and most of all our expert’s insight results in a comprehensive report with clear interpretation of the finding and suggestions for corrective actions.
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.