Case Study: Plant-wide Validation Review

A medium size manufacturer of disposable therapeutic products needed to determine the status of the process validations for one of their foreign manufacturing plants. The plant manufactures hundreds of SKUs across dozens of product lines.

AlvaMed supplied a small team of engineers experienced in both disposable manufacturing and process validation who worked on-site with the facility's manufacturing engineers. After determining that there were no Validation Master Plans for the various product lines, they reviewed hundreds of processes and process validation documents, determining which were adequate or not and which were missing altogether.

A detailed report on the validation status of every process at the facility was delivered to senior management, together with the detailed data that would be required to generate the over forty validation master plans that would be required.
 

 Bob DiNitto
 Vice-President
 Quality Assurance,
 Regulatory Affairs,
 & Design Control