Drugmaking processes change constantly. New companies enter the supply chain, old ones drop off. New production machinery and software supplant old stuff. Things get complicated and before you know it, your files are filled with new specifications and revised SOPs.
But the FDA likes things simple, clear cut and well tracked. That leaves you a lot of questions:
Co-authored by GMP experts with international reputations, Pharma Change Control is the perfect starting point to rein in your pharmaceutical manufacturing processes.
Every page offers practical strategies to implement a company-wide change control program and meet FDA regulatory requirements, including:
Look at what our experts have done for you! Check out the sample Change Control Procedure and a sample Change Control Form included in the report. You could spend weeks creating these documents from scratch, let alone thousands of dollars in staff and consultant time. But they’re yours at no extra cost when you purchase your copies of Pharma Change Control.
Meet your guides, co-authors Dr. Michael Hiob and Thomas L. Peither:
Life would be simpler if you didn’t have to worry about change control — but you do. Drugmaking is too complex and FDA requirements too stern. If you wait for the FDA to gig your drug GMP procedures, you’ve waited too long. Don’t take that risk.
Pharma Change Control: Strategies for Successful Company-Wide Implementation is available in print or PDF format.
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