top of page

PRODUCT AND PROCESS INVESTIGATIONS

 

Rita has considerable experience with problematic product and manufacturing process investigations which led to successful remediation of the issues.  Her efforts saved companies from incurring substantial product losses and manufacturing shutdowns.    She worked with a variety of staff across all disciplines and departments to gather data and eventually identify root causes, followed by appropriate corrective and/or preventative actions (CAPAs).   While many actions were implemented right away, others required updating regulatory filings, and/or vendor actions.  If you are encountering any of the following challenges, then Cooney Pharma can help. 

 

  • Problematic products and/or manufacturing processes

  • Sudden or continual OOS and atypical analyses on existing commercial products

  • Stability failures and/or changes in impurity profiles or levels

  • Problematic test methods or inappropriately set specifications

  • Reference Standard procurement and qualification

  • Struggling to get to the root cause(s) and implementing appropriate corrective and preventative actions (CAPAs)

  • Quality concerns with API or excipient vendors

  • Primary and/or secondary-source API qualification challenges

 


 

 

 

bottom of page