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.
