GLP Compliance

GENEWIZ maintains all laboratory practices in full compliance with the Code of Federal Regulations Title 21-Part 58 (21 CFR 58) for Good Laboratory Practices. Our Quality Assurance Unit (QAU) oversees all aspects of projects under FDA regulation and provides a full, customized report meeting requirements for FDA applications.

GENEWIZ Quality System

Quality by Design

• GENEWIZ GLP-compliant laboratories in New Jersey and California
• Regulatory compliance and SOP training
• Method and Assay Validation procedures
• Test Study Protocol Preparation and Reporting customized to customer requirements
• Document and Change Control
• Vendor Qualification Program to ensure use of vendors that meet GENEWIZ standards

Quality by Assurance

• Out of Specification (OOS) Investigation System to investigate unexpected and abnormal results
• Corrective Action/Preventive Action (CAPA) System to identify root cause and continuously improve quality
• Quality Trending System to identify any variation or concerning trends
• Regular internal audit and management reviews

Quality by Infrastructure

• Sample Handling and Tracking System in the facility to control sample check in, processing, storage and disposal
• Laboratory with restricted access
• Installation, Operational and Performance Qualification (IQ/OQ/PQ) Program for key instruments
• On-site fire-resistant data archiving
• Offsite data backup storage

For more information, please contact GENEWIZ.