Quality at Woodstock

Quality is our passion

Quality is a passion at Woodstock Sterile Solutions in every phase of our business.  It is foundational to our business and stems from our core belief that there is a child, a family member, or a friend, behind every dose.  Therefore, it is imperative that we are right the first time and every time.

It starts from the beginning when the molecule enters our doors. Every project is assigned a Quality Assurance Product Manager. They oversee the quality aspect of the development and manufacturing process and interact directly and consistently with counterparts at our customer.

This commitment carries over into our Commercial Operations, where the Quality Team has responsibility for material inspection and release, day-to-day Quality and Compliance oversight of product manufacturing, routine customer engagement, and batch record review and disposition for every product released from our facility.

At Woodstock Sterile Solutions, we are guided by Quality By Design fundamentals – which are intrinsic to our manufacturing technology. We are inspection-ready every day and our systems are rigorously challenged with regular customer and regulatory audits of our quality processes.  We have an excellent regulatory track record and strive to improve with every audit.

Quality Control (QC) / Quality Assurance (QA) at Woodstock Sterile Solutions

  • Chemistry Laboratory
  • Microbiology Laboratory
  • Sterility Assurance
  • Validation
  • Quality Systems
  • Incoming QA
  • Incoming QA
  • Manufacturing QA
  • Environmental Monitoring
  • QA Batch Release
  • QA Product Managers

Quality and Sterility Assurance

  • The USP recognizes BFS as an advanced aseptic process for forming, filling, and sealing containers
  • Containers are formed, filled, and sealed in a continuous operation
  • Limited container open time
  • Minimal aseptic interventions
  • Routine Aseptic Process Simulations (Media Fills)
  • Highest quality standards in the industry

Quality Control at Woodstock Sterile Solutions

Quality Control Laboratories

Chemistry

Microbiological

Validation

QS team

Manufacturing QA team
(test the product)

QC Batch Release team

QA product managers
(customer-facing)

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