24 Elements of a Successful
Supplier Quality Agreement

Do you want the confidence that you have your suppliers under control?

Would you like the ability to craft a supplier quality agreement that covers all bases?

How about a model for a quality agreement the FDA will approve?

Today’s minor mistake by your supplier could easily turn into tomorrow’s major recall. And if you don’t catch all the oversights in your quality agreement, odds are the FDA will.

In this FDANewsBrief, 20-year industry veteran Steven Sharf, explains the elements that need to go into your quality agreement:

  1. Calibration and Maintenance
  2. Batch Documentation
  3. Change Control
  4. Deviations / OOSs
  5. Field Alerts / Recalls
  6. Material Inspection / Testing / Release
  7. Labeling Controls
  8. Rejected Materials
  9. Complaint Handling
  10. APR / PQR Inputs
  11. Audits / Inspections
  12. Specifications
  1. Subcontracting
  2. Dispute Resolution
  3. Technical Transfer
  4. Validation / Qualification
  5. Warehousing and Distribution
  6. Record Retention
  7. Sample Retention
  8. Reprocessing / Reworking
  9. Supplier Qualification
  10. Stability Programs
  11. Contact List
  12. Responsibility Matrix

Use this 24-point plan to make sure you’ve covered all your bases and keep your suppliers well in hand. Order your copy today.


PDF Edition

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Who Will Benefit

  • Auditors
  • Compliance officers
  • Engineering and design controls teams
  • Executive management
  • Managers
  • Manufacturing directors and supervisors
  • Pharmaceutical and cGMP auditors
  • QA/QC personnel
  • Risk management specialists
  • Strategic planning and business development staff
  • Validation specialists, scientists, engineers

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