FDA Compliance Experts Advise Against Treating Minor Changes As ‘Planned Deviations’
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.
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The Quality Lowdown: Blast From Past At Sun Mohali, Touch Of Future With IT/OT Integration
Ranbaxy consent decree is invoked again after the FDA’s latest inspection unveils backdating at Sun’s Mohali plant. FDA probes Intas plant’s many deceptions, Ipca stumbles on investigations without start dates and Sure-Biochem must admit missing client’s contamination.
How The US FDA Is Checking For Adequate Controls Against DEG/EG Ingredient Substitution
Agency has increased its efforts to protect the US market from the diethylene glycol and ethylene glycol adulteration linked to hundreds of deaths in seven countries with testing, remote records requests, inspections, import alerts and more. Manufacturing quality compliance director Francis Godwin stresses importance of testing every container, while sharing tips for simplifying the task.
The Story Behind DuPont’s Unprecedented Excipient Warning Letter And Tips On How To Avoid Another
Insights from the FDA’s Francis Godwin on how the agency came to issue a warning letter to a DuPont excipient plant and how the normally under-the-radar sector can ensure GMP compliance.