As recently as January/February, FDA Warning Letters were issued to a variety of companies for a host of reasons, not the least of which was sterility issues. 

A Warning Letter was issued in part for failure to follow “written procedures describing the receipt, identification, storage, handling, sampling, testing and approval or rejection of drug components and drug product containers and closures.” 

At issue was a lack of quality oversight and inadequate corrective action, preventive action (CAPA). In addition, the company did not follow standard operating procedures for sanitizing water.  This led to possible contamination of the product. 

A simple solution to this issue is Westar^® Ready-to-Use components.  By moving the process of validation and quality upstream to West, customers are relieved of the burden of testing and can rest assured that West provides high-quality components that are ready-to-use in fill lines. 

Learn more about regulatory emphasis on process validation here.

For more information about our Westar products, click here.