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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 FDAnews Brief, 20-year industry veteran Steven Sharf, explains the elements that need to go into your quality agreement:
Calibration and Maintenance
Batch Documentation
Change Control
Deviations / OOSs
Field Alerts / Recalls
Material Inspection / Testing / Release
Labeling Controls
Rejected Materials
Complaint Handling
APR / PQR Inputs
Audits / Inspections
Specifications
Subcontracting
Dispute Resolution
Technical Transfer
Validation / Qualification
Warehousing and Distribution
Record Retention
Sample Retention
Reprocessing / Reworking
Supplier Qualification
Stability Programs
Contact List
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
Available Format
PDF Edition — $177
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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