Print Edition - SOPs: A Guide to Writing and Maintaining Standard Operating Procedures

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September 2009
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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:

  • "SOP? What's that?"
  • "Yeah, I've seen 'em around. Don't think anyone reads 'em though."
  • "Documentation? What documentation?"

The FDA finds a host of more common offenses too — outdated SOPs, SOPs that don't accurately describe processes, and staff that isn't trained on SOPs, to name a few.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:

  • A thorough understanding of the regulatory requirements for SOPs
  • A strategy for building a set of SOPs from scratch
  • How to assess existing SOPs and look for weak spots
  • Tips on writing clear and effective SOPs
  • Best practices for developing SOPs that will actually be followed
  • How to balance concerns of underwriting and overwriting when evaluating SOPs
  • Step-by-step guide to determine optional SOP formats
  • Ways to create review and approval procedures to fit your corporate structure
  • What the FDA looks for in SOP compliance and training
  • And much more!

    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.

Table of Contents

  • Regulatory Requirements and Expectations
  • Best Practices for SOP Development
  • How to Write and Format a First-Rate SOP
  • Maintenance of SOPs
  • Compliance and Training
  • What to Expect During an Inspection
  • Appendix A: SOP Warning Letter
  • Appendix B: Sample SOP
  • Appendix C: Sample SOP Format
  • Appendix D: SOP Quick-Guide for Writers
  • Appendix E: 11 Points to Keep in Mind While Writing SOPs
  • Appendix F: Sample SOPs From Government Agencies

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