1.OBJECTIVE:
To lay down a standard procedure for Optical Checking of filled vials and ampoules.
2.SCOPE:
This procedure provides a standard method of optical checking of filled Vials and Ampoules for the presence of any foreign particles.
3.RESPONSIBILITY:
Supervisor - Visual checking.
Senior Chemist.
Head - Production.
4.PROCEDURE:
4.1.Check and make sure that Line clearance is duly checked and signed by QA Personal as per SOP No:P/P/049
4.2.Transfer the filled ampoules/vials into the plastic crates with proper labelling and given for individual checking.
4.3.Keep the ampoules/vials in an inverted position to check for sealing, black particles under white board and Glass pieces, white pieces & fiber particles under black board by shaking the Ampoules/Vials for two to three times.
4.4.If necessary clean the ampoules/vials with a wet cloth.
4.5.Segregate and put the good and rejected Ampoules/Vials in the respective crates with lids.
4.6.Put green label for good Ampoules/Vials.
4.7.Put pink label for rejected Ampoules/vials.
4.8.Collect and send 10 to 20 Nos of good Ampoules/Vials for In-process checking.
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