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FDA Compliance Experts Advise Against Treating Minor Changes As ‘Planned Deviations’

 
• By Bowman Cox

It’s all about change control and risk management, FDA compliance experts tell rapt audience at PDA/FDA conference when confronted with the common practice of planning deviations so that production won’t falter.

How to achieve compliant pharmaceutical manufacturing without resorting to oxymorons like 'planned deviations'

Key Points:

  • If you know you’re going to deviate from SOPs, don’t call it a “planned deviation.” Call it a “temporary change control” or simply a “deviation.”

The subject of planned deviations made for a raucous “Breakfast with the FDA” session Sept. 25 at the Parenteral Drug Association/FDA conference in Washington.

These are the deviations from standard operating procedures that workers carry out on purpose, typically to keep a pharmaceutical plant...

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