#analytical test

C O N T E N T S: KEY TOPICS About the R&D 100 Awards The R&D 100 Awards recognize the top technology products of the year.(More…) Known as the “Oscars of Innovation,” the R&D 100 Awards honor the top technological advances of the year.(More…) R&D 100 Awards have a 50+ year history of honoring excellence in technology innovations.(More…) POSSIBLY USEFUL Three software products named among 100 most…

In the two years since the publication of FDA's final process validation guidance (1), how has this new lifecycle approach affected the way the industry performs validation? BioPharm International spoke with Hal Baseman, COO and principal at ValSource LLC and co-leader of the Parenteral Drug Association Process Validation Interest Group; Paul Smith, EMEAI laboratory compliance product specialist at Agilent; and Ian Jones, CEO, and Luke Kiernan, technical services director, of Innopharma Labs in Dublin, about the impact FDA's process validation guidance has had on analytical testing and validation.

CONTINUOUS PROCESS VERIFICATION

BioPharm: What are the key elements of continuous process verification?

Jones (Innopharma Labs): A manufacturer can only truly understand their process and successfully demonstrate continued process verification through the implementation of process analytical testing (PAT) technologies to support the monitoring and control of product critical to quality attributes. I think material understanding throughout the manufacturing process from the product development phase onwards will not only support a robust commercial manufacturing process but can also reduce the burden of scale-up and technology transfer, thereby supporting product-divestment initiatives. The implementation of the new FDA guidelines on process validation will not only meet the expectations of the regulator but can also ensure the success of business demands such as lean scale-up, commercial manufacture, and technology transfer.