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| RCA-0001-26 | 05/01/2026 | As per DR-0001-26-P, during the Performance Qualification (PQ) of the self-adhesive auto-labeling machine, wrinkling of labels was observed due to incompatibility of label dimensions with the bottles. | During the Performance Qualification (PQ) of the newly installed self-adhesive auto-labeling machine, wrinkling of labels was observed on Zi-AD bottles because the labels procured were based on the artwork of the benchmark product Klevra OS 60?ml, which is manually labeled. Since Zi-AD was recently transferred to the auto-labeler, the labels were not adjusted to provide the margin of play required for automated application. This caused the labels to extend onto the bottle shoulder, resulting in wrinkling. The root cause was the use of labels designed for manual labeling on a newly installed auto-labeling machine without considering the required margin of play for automated labeling. | Process was stopped and deviation has been raised. | 5 Why's | Closed | Muneeb Shahid | Pharma | Muneeb Shahid | 06/01/2026 15:58:47 | Muneeb Shahid | 12/01/2026 13:06:28 |
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| RCA-0002-26 | 09/03/2026 | As per DR-0002-26. The old artwork unit carton (Material Code: 1200000776) were issued as per the pick list for Guatemala (export) PS packs, instead of revised artwork unit cartons. As a result, over printing was performed on the old artwork unit cartons and afterwards new picklist was issued for issuance of New Artwork unit carton. | Old artwork unit cartons were issued because the picklist was generated before the decision of artwork revision and revised picklist was issued because supply chain has rights in SAP to revise the picklist without approval from QA. | Printed Unit Cartons (Material Code:1200004645) Lot no: 68511 were placed on hold and has deviation has been raised. | 5WHY | Closed | Syed Zohaib Ali | Pharma | Syed Mohammad Zohaib Ali Rizvi | 17/03/2026 10:08:50 | Syed Mohammad Zohaib Ali Rizvi | 08/04/2026 10:56:32 |