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Quality & Regulatory Compliance System to Mitigate Risks

Quality & Regulatory Compliance System to Mitigate Risks

Single-use systems have been proven to enable a more flexible and cost-effective approach to biopharmaceutical manufacturing. However, they must also meet the rigorous quality parameters and standards related to component qualification, manufacturing operations, in-process testing, and final product release.

VWR has implemented a fully documented quality system that is precisely managed with validated processes. Our quality systems, processes, facilities, and personnel are established and integrated to ensure the end user is consistently receiving the reliable products necessary, assuring the performance, robustness, and sterility of single-use systems with full lot traceability. To support these claims, a detailed Certificate of Compliance accompanies all single-use assemblies. Additionally, backing certifications for assembly components are retained by VWR and are readily available upon request.

Other key aspects of our Quality & Regulatory Compliance System include:

Redundant Cleanroom Manufacturing Facilities

  • Certified ISO Class 7 assembly rooms
  • Validated equipment and processes

Certified ISO 9001 Quality System

  • Compliant with FDA and EU cGMP requirements
  • Robust and timely Complaint Handling and CAPA programs
  • Risk-based quality management approach

Complete Regulatory Compliance Program

  • Animal Origin Free or EMA/410/01 compliant materials
  • Sterility Validation per ANSI/AAMI/ISO 11137 (VDmax25)
  • Sterile Barrier Shelf-Life Validation per ANSI/AAMI/ISO 11607
  • Endotoxin USP <85> & Particulate USP <788> lot release testing available
  • BPOG Standardized Extractables Testing Protocol in use