Ref. SOP No. QAG/2/014

PHARMEVO (PVT.) LTD.

Document No. QAG/5/079

Title: Deviation Log Book - Pharma


 
 DR NoDeviation Generation DateDeviation Submission QADateArea Of DeviationCategoryDeviation Related ToBatch NoDeviation DescriptionRCA NoCAPA NoDeviation Closed Out StatusClosed Out DateCreated ByCreated OnUpdated ByUpdated On
DR-0001-26-P02/01/202602/01/2026ProductionMinorZI AD Labeling issue5N281During labeling on the self-adhesive auto-labeling machine, label wrinkling was observed due to incompatibility between label and bottle dimensions. RCA-0001-26CAPA-0001-26Closed05/01/2026Muneeb Shahid02/01/2026Syed Mohammad Zohaib Ali Rizvi16/06/2026
DR-0002-26-P02/03/202609/03/2026Packaging areaminorIssuance of old artwork Unit carton for Guatamala (export) PS) 5L128The old artwork unit cartons (Material Code: 1200000776) Lot no: 68511 were issued for packaging of Guatemala (Export) PS packs instead of the revised artwork unit cartons. Consequently, overprinting was performed on the old artwork unit cartons. RCA-0002-26CAPA-0004-26Closed09/03/2026Syed Mohammad Zohaib Ali Rizvi09/03/2026Syed Mohammad Zohaib Ali Rizvi16/06/2026
DR-0003-26-P09/03/202609/03/2026Production majorHardness results exceeding the upper control limit6B302During compression of Avsar Plus 160/10/25, Batch No. 6B302, on the ZPW-23 compression machine, tablet hardness values were observed to be in the range of 5–20 kg, exceeding the upper specification limit of 15 kg as defined in the approved BMR.N/ACAPA-0005-26Closed09/03/2026Syed Mohammad Zohaib Ali Rizvi09/03/2026Syed Mohammad Zohaib Ali Rizvi18/06/2026
DR-0004-26-P07/04/202608/04/2026ProdutionMajorCAM Breakage During Compression6C209During compression of Sacvin 100 mg Tablets, Batch No. 6C209, on ZP37B-II Compression Machine, CAM breakage occurred due to loosening of the CAM bolt during operation. RCA-0003-26CAPA-0007-26Closed08/04/2026Syed Mohammad Zohaib Ali Rizvi09/04/2026Syed Mohammad Zohaib Ali Rizvi18/06/2026
DR-0005-26-P15/05/202615/05/2026Production minorSpillage of material 6F040During granulation of Nise 100 mg Tablets, Batch No. 6F040, while off-loading the materials from cage onto a pallet, the polybags containing Colloidal Silicon Dioxide (Aerosil 200), Talcum Powder, and Magnesium Stearate accidentally slipped from the cage and fell onto the floor. Consequently, all three polybags got ruptured, resulting in spillage of the materials onto the floor. RCA-0005-26CAPA-0011-26Closed18/05/2026Syed Mohammad Zohaib Ali Rizvi15/05/2026 17/06/2026
DR-0006-26-P 23/05/202623/05/2026Production MinorBGK Coating 350 tripped and could not restart6D138During startup of BGK-350 for film coating of Erlina Plus XR 25/5/1000 mg Tablets, the BGK-350 Coating machine tripped and could not restart. RCA-0006-26CAPA-0012-26Closed25/05/2026Syed Mohammad Zohaib Ali Rizvi25/05/2026Syed Mohammad Zohaib Ali Rizvi03/07/2026
DR-0007-26-P 25/05/202625/05/2026Production majorWeight variation observed during Encapsulation6B259During encapsulation of Zoltar 20mg Capsule, weight variation observed to be exceeding the defined limits.RCA-0007-26CAPA-0013-26Closed25/05/2026Syed Mohammad Zohaib Ali Rizvi25/05/2026Syed Mohammad Zohaib Ali Rizvi18/06/2026
DR-0008-26-P 15/07/202615/07/2026         Syed Mohammad Zohaib Ali Rizvi15/07/2026  
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2024-2025 QA.