1.
A flaw with slight or negligible severity
2.
A metal holder used for certain products to angle the vials at 45 prior to inspection
3.
A tray, tub, or bin used to hold individual final product units or primary containers
4.
To make the active ingredient, inactive to achieve a state that is acceptable for receipt by a third party laboratory
5.
A person capable of performing the task in lieu of the assigned responsible person
6.
A time period of no less than five minutes away from VI
7.
A slender, threadlike particle having an aspect ratio of 3:1 or greater
8.
Visual Particulate matter. A noncomformity that is potentially hazardous to the patient
9.
A noncomformity leading to serious impairments, for example a malfunction that makes the packaging unusable or reduces efficeincy in the production
10.
An inspection lightbooth
11.
A nonconformity that does not impair product quality or process
12.
Matter that does not have an aspect ratio of 3:1 or greater
13.
The closure of syringe primary container
14.
A primary, final product container such as a vial or syringe
15.
Primary Container is of the Wrong Type
16.
Cracked,Broken, or otherwise Non-Integral Primary Container
17.
Missing or Incorrectly Seated Stopper
19.
Stopper is of the Wrong Type
20.
Seal is of the wrong type
23.
Empty Primary Container
24.
Cloudy or discolored solution
25.
dark colored particles/metal
26.
light colored particles/glass
30.
incorrectly seated, improperly or partially crimped seal
31.
product at the vial crown
32.
plunger stopper position/Sam's initials
33.
cosmetic stopper defects
34.
seal or cap discoloration
35.
gross denting of the seal or missing flip-off button
37.
A media filled unit that is likely to result in personal injury to the patient.
