Qualification of Inspectors for visual inspection (Knapp Test)

2.0      Scope: Final visual inspection is performed manually by human operators. 

 Prior to being qualified as an inspector, each inspector must be successfully trained and qualified per this procedure.

Qualification Criteria

• Inspectors are qualified if their detection of rejects is ≥ 70% detection of known rejects and ≤ 30% of blanks (false reject) in any given test set.
• The inspector must meet this requirement three (3) times before being considered a qualified manual visual inspector

Re-Qualification Schedule

1.  Visual inspectors are re-qualified annually.
2. If inspection performance declines, re-qualification may be required in shorter time-frames.
3. Annual eye sight exams at optometrist for visual acuity with 20/20 vision or 20/20 corrected. If eyesight is corrected with eye glasses or contact lenses, then those must be worn during the product inspection process.

References:.

1.    USP , Injections and Implanted Drug Products (Parenterals) – Product Quality Tests

2.    USP Visible Particulates in Injections 3.    USP Visual Inspection of Injections

Responsibilities:

1. It is the responsibility of the Production Manager/Production Officer to ensure that visual inspectors are qualified  per this SOP.
2. It is the responsibility of the Quality Assurance (QA) to perform investigations of inspectors who do not meet requalification requirements.

Procedure:

A. The inspection process is designed to ensure that 100% of every container

Of every lot of parenteral preparations is “essentially free” from visible particulates.

 1. Different test sets needed for each drug product category.

• Clear Liquid
• Suspension
• Others

2.  Test sets can be made up of production rejects or created manually with

Characterized particulate material.  Test sets are made up of

blank ampoules,Ampoules with particles/fiber Misprinted Sealing defect

3. Test sets are labeled so as to keep the identity of the rejects unknown to the trainee.

4. Units that are no longer usable in a test set due to breakage, particle no longer detectable; cake breakage, etc. will be replaced.

B. . Qualify an inspector using a test set that is representative of the product to be inspected.  For example, if the product to be inspected contains gel, qualify the inspector using the test set containing gel

1. Inspectors are qualified if their detection of rejects is ≥ 70% detection of known rejects and ≤ 30% of blanks (false reject) in any given test set.  . The inspector must meet this requirement three (3) times before being considered a qualified manual visual inspector.

2. The trainee is trained on the operation of the manual inspection booth.

3. The trainee is shown the rejects within the test set to be trained upon.
Each of the rejects is described as the trainee inspects the rejects within the test  set. A blank is also given for inspection as well.

4. Ensure that operators spend appropriate time (5+ seconds against each
colored background) with each product container during the visual inspection process

5. The reject vials are then mixed in with the rest of the test set and the trainee inspects each vial while being observed by the trainer.  The trainee inspects all of the vials and notes the defect code for the reject vials while maintaining separation of the rejects and the blanks.

6. Upon completion the trainer compares the trainee’s determinations to the
actual defects/blanks. ≥ 70% detection of known rejects and ≤ 30% of blanks (false reject) is required to pass.  The trainee repeats the inspection process until successfully passing three (3) times

Inspector Re-Qualification Schedule:

1.Visual inspectors are re-qualified annually.

2.If inspection performance declines, re-qualification may be required in shorter time-frames.

3.Common causes of declined performance that may lead to a need for re-

qualification include fatigue, demonstration of an improper reject rate during operations, etc. and/or causing excessive product investigations.

4. Annual eye sight exams at optometrist for visual acuity with 20/20 vision or 20/20 corrected.  If eyesight is corrected with eye glasses or contact lenses, then those must be worn during the product inspection process.