GDP
What is a single line-through, initial and date?
This tool repeatedly asks "Why?" to find the underlying cause.
What is the 5 Whys?
Auditors rely on this to support findings.
What is objective evidence?
A defect found before shipment.
What is an internal defect?
This process ensures materials from one job are removed before the next job begins.
What is Line Clearance?
These ink colors are the only GMP compliant colors.
What is blue or black
Retraining is generally considered this type of CAPA.
What is a weak CAPA?
If an auditor requests a record, employees should provide this.
What is the current approved document?
A defect found by the customer.
What is a customer complaint?
This information must always be visible on material status labels.
What is job number and status identification?
This should never be used on GMP documentation.
What is white-out or correction fluid?
A process change that physically prevents operator error is an example of this.
What is a strong CAPA?
This demonstrates material status on the production floor.
What is proper labeling and identification?
Bent inserts are found in the center of a tray. What should occur?
What is segregation and investigation?
Inserts, cartons, and labels should be checked against this before use.
What is the customer specification or job ticket?
ALCOA+ principles are used to ensure this.
What is Data Integrity?
This verifies that a CAPA actually solved the problem.
What is an Effectiveness Verification?
The phrase "I think" should be replaced with this.
What is, "Let me verify and provide the correct information"?
This tool confirms barcode readability.
What is a barcode scanner?
Mixing two customer lots of inserts together creates this significant risk.
What is a product mix/admix risk?
A production record contains a blank field because the activity was not applicable. What should have been entered?
What is "N/A"
Operators skip verifications because forms are difficult to complete. What is the likely root cause?
What is a process/system issue?
An auditor discovers an unlabeled container.
What is a potential GMP compliance finding?
Which defect carries the greatest risk: cosmetic scratch, bent corner, or incorrect component?
What is an incorrect component?
During production, an unlabeled pallet of packed trays is discovered. What action should be taken?
What is place the material on hold and investigate its identity and status?