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Document 1 - ID: 65aa273f60e5686f91fb8507 
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Document 2 - ID: 65aa28e260e5686f91fb8532 
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Document 3 - ID: 65aa2c9b60e5686f91fb856c 
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Document 4 - ID: 65aa384260e5686f91fb8601 
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Document 5 - ID: 65aa38a160e5686f91fb8627 
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Document 6 - ID: 65aa393f60e5686f91fb864d 
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Document 7 - ID: 65aa3a0e60e5686f91fb865a 
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Document 8 - ID: 65aa3a9460e5686f91fb8670 
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Document 9 - ID: 65fa9ff45fd921564589c1c3 
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Minor process changes in the manufacturing stages ofLoperamide HCl, which does not impact the Quality of the Drug substance.\n2. ncluded Additional source of one of the Key Starting Materials\n3. Discussion on GTI impurities is updated\n4. Discussion on Nitrosamines is provided\n5. Revised Specification and Test procedure ofLoperamide HCl Ph.Eur of both Unit-I and Unit-II is provided.\n6. Updated Analytical Validation Report for Residual solvents by GC is provided.\n7.Certificate of Analysis in-line with updated specification and test procedure of drug substance Loperamide HCl Ph.Eur is included.", "choices": []}, {"_id": {"$oid": "655f2615c7e4e91e47f968a7"}, "externalId": "nameOfTheMaterial", "displayName": "Name of the Material", "value": "Loperamide Hydrochloride Ph.eur", "choices": []}, {"_id": {"$oid": "655f2663c7e4e91e47f968a8"}, "externalId": "typeOfMaterialOrService", "displayName": "Type of Material or Service", "value": "API", "choices": []}, {"_id": {"$oid": "655f2680c7e4e91e47f968a9"}, "externalId": "vendorDetails", "displayName": "Vendor Details", "value": "VASUDHA PHARMA CHEM LIMITED, \nUnit-I, Plot No. 37/A, 38, 39A&B, Phase-I, I.D.A., Jeedimetla India-500055 Hyderabad, Telangana\nAnd\nUnit-II, Plot No.79, Jawaharlal Nehru Pharma City, Parawada Mandal,Anakapali District, India-531019 Thanam Vilage,Andhra Pradesh\n", "choices": []}, {"_id": {"$oid": "655f2699c7e4e91e47f968aa"}, "externalId": "remarks", "displayName": "Remarks", "value": "Summary of changes shall be assessed and discussed with CFT. in case of impact on specification and STP, CC shall be iniitated and addressed.\n\n*Change notification is received in march however the number was logged as THM/CN/24/JAN/0001 instead of THM/CN/24/MAR/0001. (typo error corrected on 16/04/24)\n\n Change Control Record ID: 409792", "choices": []}, {"_id": {"$oid": "655f24fcc7e4e91e47f968a0"}, "externalId": "createdAt", "displayName": "Created At", "value": "1710923764"}, {"_id": {"$oid": "655f24fcc7e4e91e47f968a1"}, "externalId": "updatedAt", "displayName": "Updated At", "value": "1714633719"}, {"_id": {"$oid": "655f24fcc7e4e91e47f968a2"}, "externalId": "createdBy", "displayName": "Created By", "value": "345080495733071872"}, {"_id": {"$oid": "655f24fcc7e4e91e47f968a3"}, "externalId": "updatedBy", "displayName": "Updated By", "value": "345080495733071872"}, {"_id": {"$oid": "655f24fcc7e4e91e47f968a4"}, "externalId": "usageStatus", "displayName": "Usage Status", "value": "1"}], "relations": [], "modifiedAt": 1714633719, "createdAt": 1710923764, "createdBy": {"_id": "345080495733071872", "employeeId": "3134", "firstName": "Diksha", "lastName": "Hegde"}, "modifiedBy": {"_id": "345080495733071872", "employeeId": "3134", "firstName": "Diksha", "lastName": "Hegde"}, "usageStatus": 1, "facilityId": "1665458801", "shortCode": "yHCkrLxh96", "searchable": {"655f25acc7e4e91e47f968a5": 1710873000, "655f24fcc7e4e91e47f968a4": 1, "655f24fcc7e4e91e47f968a3": 345080495733071872, "655f24fcc7e4e91e47f968a2": 345080495733071872, "655f24fcc7e4e91e47f968a1": "1714633719", "655f24fcc7e4e91e47f968a0": 1710923764, "655f24fcc7e4e91e47f9689f": "THM/CN/24/MAR/0001*", "655f24fcc7e4e91e47f9689e": "CN Log 2024", "655f25d9c7e4e91e47f968a6": "1. Minor process changes in the manufacturing stages ofLoperamide HCl, which does not impact the Quality of the Drug substance.\n2. ncluded Additional source of one of the Key Starting Materials\n3. Discussion on GTI impurities is updated\n4. Discussion on Nitrosamines is provided\n5. Revised Specification and Test procedure ofLoperamide HCl Ph.Eur of both Unit-I and Unit-II is provided.\n6. Updated Analytical Validation Report for Residual solvents by GC is provided.\n7.Certificate of Analysis in-line with updated specification and test procedure of drug substance Loperamide HCl Ph.Eur is included.", "655f2663c7e4e91e47f968a8": "API", "655f2699c7e4e91e47f968aa": "Summary of changes shall be assessed and discussed with CFT. in case of impact on specification and STP, CC shall be iniitated and addressed.\n\n*Change notification is received in march however the number was logged as THM/CN/24/JAN/0001 instead of THM/CN/24/MAR/0001. (typo error corrected on 16/04/24)\n\n Change Control Record ID: 409792", "655f2615c7e4e91e47f968a7": "Loperamide Hydrochloride Ph.eur", "655f2680c7e4e91e47f968a9": "VASUDHA PHARMA CHEM LIMITED, \nUnit-I, Plot No. 37/A, 38, 39A&B, Phase-I, I.D.A., Jeedimetla India-500055 Hyderabad, Telangana\nAnd\nUnit-II, Plot No.79, Jawaharlal Nehru Pharma City, Parawada Mandal,Anakapali District, India-531019 Thanam Vilage,Andhra Pradesh\n"}, "_class": "com.leucine.streem.collections.EntityObject"}
Document 10 - ID: 661e0c07f6bd4a47fed11900 
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