Quality Assurance

Quality is an integral part of Paragon’s business practices. Quality management systems are implemented to comply with the internal policies as well as with national and international regulations and guidelines.

Our scientists, engineers, laboratory and manufacturing teams interact directly with clients to understand their specific requirements, ensuring products are manufactured to meet strict current Good Manufacturing Practice (cGMP) requirements and customer-defined specifications.

At Paragon, quality is built into all of our services to ensure that products are consistently produced and controlled according to quality standards. Our quality systems cover all aspects of manufacturing from the starting materials, premises and equipment and to the training of staff.

Using extensive compliance and regulatory experience, our quality complies with established plans while focusing on meeting customer and regulatory requirements.

Quality Control

The QC Team maintains the air quality environmental testing program for all classified operating spaces, USP water testing and clean steam testing. Sampling is performed in active areas weekly and as a part of the change-over procedure.

These programs are supported by performing routine microbiological assays, bioburden testing, conductivity, TOC, endotoxin. Air quality standards are applied to viable and nonviable air quality samples.

The QC Team also performs sampling for the raw material testing program. The majority of raw material samples are sent to the qualified contract laboratory for analysis. We can perform ID or full compendia testing. Instrumentation in the QC laboratory has been qualified prior to use for sample analysis.

Test methods are documented in Standard Operating Procedures. The client provided test methods are transferred into the QC laboratory following a formalized process that is approved by quality assurance and the client. Method transfer includes specificity, precision and sample stability testing. Test methods are qualified or validated to the level required by the intended use of the test method. Method qualification includes linearity, accuracy, precision, and selectivity (stability indicating properties).