Quality Control Systems

The QC analytical lab performs in-process testing, release testing, as well as management and testing for stability studies. Paragon strategically utilizes key subcontractors such as Charles River, Lancaster Laboratories, and Wuxi AppTec for select specialized analysis (e.g. cell bank characterization, viral clearance studies) when such services are more cost-effectively outsourced. The decision to outsource testing is determined jointly between the client and the QC laboratory. Contract test laboratories are qualified by QA and QC prior to use for testing services.

The QC Team maintains the air quality environmental testing program, 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 qualified contract laboratory for analysis. We can perform ID or full compendia testing. Currently testing can be performed to meet either US or EU regulations.

Instrumentation in the QC laboratory has been qualified prior to use for sample analysis. Test methods are documented in Standard Operating Procedures. 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).

QC laboratory equipment

Environmental Monitoring Devices
pH/Conductivity Meter
TOC analyzer
Endotoxin tester
Milliflex unit for Bioburden
UV/VIS spectrophotometer

Assays supported

Endotoxin
TOC
Microbial
Viability
Bioburden
Purity
HPLC (client specific methods)
Protein Concentration
Filter Integrity
ELISA (client specific methods)
SDS Page
Western Blot
pH
Conductivity
Capillary electrophoresis
Gas Chromatography