SOP for Validation of Visual Checking Inspectors : Pharmaceutical Guidelines

SOP for Validation of Visual Checking Inspectors

Standard operating procedure to qualify the inspectors working on visual inspection area in liquid manufacturing facility..

1.0 OBJECTIVE

This SOP lays down a procedure for validation of visual checking inspectors

2.0 SCOPE

This is applicable to the personnel assigned the job for visual checking during the filling/ packaging process

3.0 RESPONSIBILITY

Packing Chemist / Asst. Production Manager

4.0 ACCOUNTABILITY

Asst. Production manager / Q.A. Manager

5.0 PROCEDURE

5.1 Select 100 no. of filled bottles which contain 5 bottles with poor sealing; 5 bottle with particulate matter, 2 bottles with molding defect, 5 bottles with less or more volume; 2 bottles with glass particles and 81 clear & good bottles.
5.2 Paste 1 to 100 no. sticker or mark the cap with a suitable marker on all the bottles & make a list of all no. bottles and write the remark like a good, sealing defect particle, module, volume to identify the bottles on the sheet. This remark should be against the bottle no. and fill the form.
5.3 Ask each inspector to check the bottle against black & white background & remove the rejected bottle.
5.4 If the inspector rejects all the marked bottles he/ she passes the validation test.
5.5 If the inspector fails to identify minor rejection like small mold defect or minor sealing defect he/she shall be considered to pass the test.
5.6 If the inspector fails to identify even one major defect like the suspended particle, glass particle, volume variation he/ she fails in the validation test.
5.7 A new inspector has to pass the validation test in two consecutive test then only he/ shall be allowed to check the bottles.

6.0 ABBREVIATIONS

6.1 SOP: Standard Operating Procedure
6.2 QA: Quality Assurance
6.3 No.: Number





Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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