1.0       OBJECTIVE:

The objective of this SOP is:

1.1       To lay down a procedure for de-labeling of on line rejected labeled vials/ampoules.

2.0       SCOPE:

3.0       This SOP is applicable for de-labeling of on line rejected labeled vials/ampoules. RESPONSIBILITY:

3.1       The Operator/Officer /Executive Production shall be

3.1.1    Responsible for de-labeling of on line rejected labeled vials/ampoules.

4.0       ACCOUNTABILITY:

Manager Production / Head – Quality Assurance

5.0       PROCEDURE:

5.1       Take the line clearance for de-labeling activity from I.P.Q.A chemist.

5.2       Arrange the vials/ampoules in upright position in the cleaned plastic crate.

5.3       Fill purified water for gum labeled and IPA for sticker labeled vials/ampoules in the carat till the upper end of the vials/ampoules label is immersed.

5.4       Soak them for about 15 minutes.

5.5       Remove individual vials/ampoules and peel-off the labels.

5.6       Put all the soaked/damaged labels in polythene bag.

5.7       Wipe the de-labeled vials/ampoules dry with cloth and re label them.

5.8       After completing the labeling and packing of the batch, leftover and rejected de-labeled labels shall be reconciled and destroyed.

5.9       A destruction certificate shall be prepared and duly signed by production and IPQA Chemists.