Executive Briefing Series (formerly The Food & Drug Letter)

Last year’s process validation guidance has been called a game changer and many companies are struggling with how to comply. Many would rather ignore the guidance than have to revalidate their processes. But companies that don’t align their change controls, monitoring and trend efforts with the FDA’s new approach risk costly enforcement. That’s what happened to device giant Beckman Coulter, which received a Form 483 last summer citing problems with process validation and device design validation. And in February, Integra subsidiary Theken Spine got a 483 for not fully validating its process for cleaning returned spinal implant kits. While it’s tempting to pinch pennies in tough economic times, cutting corners on process validation can wind up costing your company millions of dollars. One way to prepare your company to defend its process validation practices and manufacturing compliance with the FDA’s 2011 guidance is to develop a process validation roadmap. This will ensure you’ve covered your cases with all three components of the guidance — process design, process qualification and continued process verification. This issue of The Food & Drug Letter looks at the FDA’s current expectations on process validation and strategies to help your company meet them.

Drugmakers sometimes avoid process improvements just so they won’t have to revalidate the process.

It’s important to be prepared to defend your company’s process validation (PV) practices and manufacturing compliance with the 2011 FDA PV guidance, especially when in discussions with the agency.

The FDA is advising drugmakers befuddled by manufacturing failures, such as product contamination by microorganisms, to perform risk assessments and take preventive action.

Drugmakers should use risk assessments to identify material attributes and manufacturing process parameters that may affect a drug’s critical quality attributes (CQAs), an International Conference on Harmonisation (ICH) draft guidance states.

Sponsors of abbreviated new drug applications (ANDA) are generally not required to include a sterility assurance quality overall summary (SA-QOS) in sterile product applications, the FDA’s Office of Generic Drugs says.

Media fills used to validate aseptic manufacturing procedures for positron emission tomography (PET) drugs should be conducted in production areas and employ the “broadest scope” of possible manipulations that could occur during actual production, according to an FDA draft guidance.

Various violations related to cGMPs, including failure to adequately validate packaging and sterilization processes, landed PhotoMedex — a maker of burn and wound dressings — an FDA warning letter earlier this year.