Labeling

Question 1

What are the line clearance responsibilities for labels?

Answer 1

Verify the number of labels received and the label part number and lot number are consistent with the issued batch record or sample plan

Question 2

What do you do with damaged labels?

Answer 2

MFG must return to QA with a SIF

Question 3

What steps are followed for label reconciliation?

Answer 3

1. Collect and count all unused and damaged labels
2. Complete the label reconciliation form
3. Return all unused labels

Question 4

Who is responsible for destroying/discarding all unused labels?

Answer 4

QA

Question 5

When placing an updated label on an already labeled item, what is the proper procedure?

Answer 5

Draw a single line across the label that no longer is accurate and place the new label near (never on top of) the old label. Initial and date the cross out.