The work performed at NewLab BioQuality is compliant to either Good Laboratory Practice (GLP, for virus and TSE safety studies) or Good Manufacturing Practice (GMP, for cell line characterization work and bulk harvest testing, lot release testing, stability studies and detection of contaminants and impurities) standards.  The results of the analysis and our reports are accepted by regulatory authorities world-wide.   An FDA audit was successfully completed in 2004.  The established quality system employs  the following principles:

• Well-trained personnel
• Traceable receiving, storage and analysis of samples
• Use of controlled and traceable materials
• Validated analytical procedures
• Qualified, calibrated equipment and instrumentation
• Sound procedures, protocols and reports
• Up to date Change Control and Deviation Control
• Well-structured, organised systems for "out of specification" (OOS) results
• Document archiving (10 years)

Our quality system insures that all analyses are transparent from the planning stage, to the execution of the study itself, and through to the reporting of the results. This type of quality service allows our clients to integrate the analytical results directly into their drug authorization documentation.  NewLab BioQuality offers a comprehensive validation program of its assays in accordance to the ICH Q2 (R1) guidelines.  The validation data can be reviewed at our facility in the context of a client audit.  Sample-specific validation is also performed when required by our client.  In order to guarantee a consistent high quality standard, we are routinely audited by:

• Internal inspections 
• Clients' audits (> 15/year from USA, Japan, EU and others)
• Regulatory authority inspections