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Every FDA-regulated company must maintain Standard Operating Procedures (SOPs) that document regulated production processes. But FDA investigators asking employees on the production floor about SOPs often are amazed at what they hear:
The FDA finds a host of more common offenses too — outdated SOPs, SOPs that don't accurately describe processes, and staff that isn't trained on SOPs, to name a few.
With the average drug or device company maintaining more than 1,200 SOPs, SOPs can quickly get out of control. The time to start straightening up your SOPs is now ... not following the next visit from FDA investigators.
SOPs: A Guide to Writing and Maintaining Standard Operating Procedures is the indispensable guide for anyone involved in producing or maintaining these crucial documents. This guide delivers:
An indispensable feature of this guide: Sample SOPs and SOP formats, providing industry standards to model your SOPs on ... plus a sample warning letter that the FDA issues for deficient SOPs.
Whether you're tasked with maintaining your company's entire SOP library or simply need to work on SOPs that affect your department ... whether you're writing your first SOP or refreshing old skills ... this guide will point you in the right direction.
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