1.0 Purpose : To provide instructions for Issuance of labels and reconciliation.
2.0 Objective : To provide a documented procedure for Issuance of labels and reconciliation.
3.0 Scope : This procedure is applicable for Issuance of labels and reconciliation for QA.
4.0 Responsibility :
· Primary: Officer – QA / Officer – Production
· Secondary: Production In-change
5.0 Procedure:
· On receipt of labels issuance request intimation / note from production department, QA shall enter the entry in label issue register.
· QA shall enter the information related to label, like Name of Product, Product Code, Product Stage, Batch Number, Manufacturing Date, Expiry Date, and required labels quantity.
· QA shall issue required quantity of labels with one extra label for BMR.
· QA shall take a receiver signature in labeling issuance register.
· Maintain the issuance record with updating labels quantity.
· If any mistake occur during filling the data on label, issue another new label and destroyed the incorrect label
· Maintain record of destroyed labels in label issue register.
6.0 Reference Document :
v Label Issue Register.
LOG BOOK FOR LABEL ISSUANCE
Sr. No. | Date of Issue | Product code | Product stage | Batch No. | No. of labels issue | Destroyed No. | Total no. of issue | Balance qty. | Issue by QA | Received by Production |
7.0 Abbreviations :
· QA = Quality Assurance department
· SOP = Standard Operating Procedure
· QC = Quality Control
8.0 Copies to Distribution Sites. :
· QA –Ankleshwar
· Production – Ankleshwar
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