We are a start-up biotech company and need to set-up a raw materials testing program. Final product labels are our current priority.

Have a copy of the master label available for the inspectors to compare directly. Several items should be inspected:

1. Number reconciliation – how many labels sent vs. the claim of how many sent?

2. Quality of printing on the labels: Record any instances of printed lines not fully on the label; readability problems; typos or other errors; any difference between the labels and the specification for the labels (size, font, content, etc.).

3. It is customary to retain at least one label in the file, in case of later complaints or issues. The label should be affixed to a form that is designed to hold the inspection information; and is kept with QA.

4. Be sure that someone checks for common sense issues– for example, you are doing a clinical trial in Europe but the label says “USA use only”. Training, and example labels, help with this.