GDP-Audit

1.0 - Lots

  • 1.1 - Incoming lot/date codes are recorded?

  • 1.2 - Outbound lot/date codes are recorded?

2.0 - Product Rotation

  • 2.1 - There is a documented procedure for rotation of product?

  • 2.2 - There are sufficient inventory/tracking records for recall?

3.0 - Recall

  • 3.1 - There is a recall team and responsibilities are identified?

  • 3.2 - 100% recovery can be accomplished with 2 hours?

  • 3.3 - There are returned product reconciliation and disposition procedures?

  • 3.4 - There are procedures for how to notify customers?

  • 3.5 - Customer contact numbers are readily available?

4.0 - Trace-Ability Test

  • 4.1 - Product can be 100% traced?

  • 4.2 - Elapsed time was less than 2 hours?

5.0 - Non-Conformancy

  • 5.1 - Non-conforming items are in a proper storage area?

  • 5.2 - Non-Conforming items are identified physically and electronically?

  • 5.3 - Destroyed product have lot/date codes recorded?

Miscellaneous

6.0 - Miscellaneous Notes

  • 6.1 - Are their any Miscellaneous Notes and/or Pictures?

Signatures

7.0 Sign Off

  • 7.1 - On Site Representative's Signature

  • 7.2 - Auditor's Signature

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