Process Validation

Process validation has been a major focus of the FDA in recent years. Our team has extensive experience in both setting up and monitoring process validation programs. This is an area where having the latest information makes all the difference. It is critical to begin thinking about process validation during the early stages of product development. Starting early will save your company potentially a significant time of delay to approval for your product. Let us help you set up a program or review your existing program for compliance with current industry trends.

Synergy Bioscience can support your organization by:

• Developing process validation master plans
• Protocols and reports
• Critical parameter selection and studies
• Evaluation of small scale studies and their applicability to full scale work
• Methods validation and other QC support functions

Synergy Bioscience also provides support by assisting with

• Process pool hold time studies buffer hold studies
• Product specific cleaning validation
• Final filter validation
• Final bulk container validation
• Shipping validation

Synergy Bioscience is also available for support of biopharmaceutical products like

• Genetic stability
• DNA and host-cell protein removal
• Clearance of process additives
• Viral clearance/inactivation
• Chromatography cleaning, storage & seuse studies
• Membrane cleaning, and storage & reuse studies