The work performed at all five Charles River Biopharmaceutical Services (BPS) sites is compliant with either Good Laboratory Practice (GLP) for safety studies such as virus and TSE screening or current Good Manufacturing Practice (cGMP) for quality studies such as cell line characterization, bulk harvest testing, lot release testing, stability studies, detection of contaminants, manufacturing and select in vivo bioassays. The results of the analysis and our reports are accepted by regulatory authorities worldwide. The established quality systems employ the following principles:
- Well-trained personnel
- Traceable receiving, storage and analysis of samples
- Well-structured SOP system
- Comprehensive internal training programs, both technical and regulatory
- Use of controlled and traceable materials
- Qualified suppliers
- Validated analytical procedures
- Qualified, calibrated equipment and instrumentation
- Sound procedures, protocols and reports
- Up-to-date change control and deviation control
- Well-structured, organized systems for out of specification (OOS) results
- Document archiving (on- and off-site)
- Sponsor-contractor quality agreements
Our quality systems ensure that all analyses are transparent from the planning stage to the execution of the study and the reporting of the results. This type of quality service allows you to integrate the analytical results directly into your drug authorization documentation. We offer a comprehensive validation program of assays in accordance to the International Conference on Harmonisation (ICH) Q2 (R1) guidelines. The validation data can be reviewed at our facilities in the context of a client audit. To guarantee a consistent, high-quality standard, we are routinely audited by:
- Internal inspections
- Clients worldwide (more than 60 per year)
- Regulatory authority inspections (FDA, IMB, etc.)