{
  "deviation_record": {
    "Deviation_ID": "DEV-2024-0312",
    "Batch_ID": "BTC0048",
    "Product": "Paracetamol Tablets 500mg",
    "Product_Code": "AURO-PARA-500",
    "Plant": "Unit III, Hyderabad",
    "Manufacturing_Line": "Solid Dosage Line-4",
    "Date_of_Occurrence": "2024-10-12",
    "Time_of_Occurrence": "08:00",
    "Date_Reported": "2024-10-12",
    "Time_Reported": "08:20",
    "Reported_By": "V. Srinivas, Sr. Production Manager",
    "Deviation_Type": "Process Deviation — Critical",
    "Severity": "Critical",
    "Status": "Under Investigation",

    "Description": "During wet granulation of batch BTC0048 (Paracetamol Tablets 500mg) on 2024-10-12, the inlet air temperature of fluid bed granulator EQP_GRAN_01 exceeded the validated upper limit of 70°C at 08:00 hrs. Temperature readings recorded in the batch manufacturing record show a progressive rise from the normal operating range: 61.2°C (07:00), 63.1°C (07:30), 68.4°C (07:45), and 74.8°C (08:00). The product bed temperature simultaneously rose to 78.2°C at 08:15 hrs, which is 8.2°C above the upper specification limit of 70°C. Granulation was stopped immediately at 08:20 hrs upon detection. A total of approximately 40 minutes of granulation was conducted under temperature exceedance conditions. Equipment EQP_GRAN_01 was taken out of service for investigation.",

    "Initial_Impact": {
      "Process_Impact": "Granulation conducted outside validated temperature range (60–70°C) for approximately 15–20 minutes. Elevated temperature may have caused partial degradation of Paracetamol API and/or alteration of granule physical properties including porosity and compressibility.",
      "Product_Impact": "Risk of reduced assay due to thermal degradation of active substance above 70°C. Potential impact on tablet mechanical properties (hardness, friability, dissolution) due to altered granule structure.",
      "Patient_Safety_Impact": "Sub-potent tablets if released would present patient safety risk — insufficient therapeutic dose. Batch quarantined — no product has left the facility.",
      "Regulatory_Impact": "Mandatory deviation report per Schedule M (India GMP) Clause 14. CDSCO notification to be assessed within 30 days."
    },

    "Immediate_Actions_Taken": [
      {"Action": "Granulation process stopped immediately at 08:20 hrs upon temperature exceedance confirmed.", "By": "V. Srinivas", "Time": "08:20"},
      {"Action": "Granules quarantined in-process. Quarantine label DEV-2024-0312-HOLD applied.", "By": "QA Analyst on-site", "Time": "08:35"},
      {"Action": "Equipment EQP_GRAN_01 taken out of service. Do Not Use tag applied.", "By": "Engineering Supervisor", "Time": "08:40"},
      {"Action": "QA Manager notified — K. Reddy informed at 08:25 hrs.", "By": "V. Srinivas", "Time": "08:25"},
      {"Action": "Maintenance team requested to inspect EQP_GRAN_01 temperature sensor and heating element.", "By": "K. Reddy, QA Manager", "Time": "09:00"},
      {"Action": "Retain samples collected from granules for additional testing.", "By": "QC Analyst", "Time": "09:30"},
      {"Action": "LIMS order raised for full release testing including assay, dissolution, and related substances.", "By": "QA Analyst", "Time": "10:00"}
    ],

    "Equipment_Details": {
      "Equipment_ID": "EQP_GRAN_01",
      "Equipment_Name": "Fluid Bed Granulator — GEA Aeromatic Fielder",
      "Equipment_Model": "Fielder PMA 600",
      "Serial_Number": "GEA-PMA600-2018-047",
      "Last_Preventive_Maintenance": "2024-07-15",
      "Next_PM_Due": "2024-10-15",
      "Last_Calibration_Temperature_Sensor": "2024-04-10",
      "Calibration_Due_Date": "2024-10-10",
      "Calibration_Status": "OVERDUE — 2 days past due at time of deviation",
      "Prior_Maintenance_Observations": "PM on 2024-07-15: Thermocouple connector showing early signs of oxidation. Noted as 'monitor at next PM'. Action deferred to next scheduled PM."
    },

    "Preliminary_Root_Cause_Assessment": {
      "Most_Probable_Cause": "Temperature sensor (thermocouple) malfunction or drift due to overdue calibration and previously noted connector oxidation. Sensor may have been providing inaccurate feedback to the PID controller, causing the heating element to continue heating beyond the setpoint.",
      "Contributing_Factor_1": "Preventive maintenance deferred — PM was due 2024-10-15, only 3 days after the deviation date. Prior PM note (2024-07-15) identified thermocouple connector oxidation as a concern but deferred action.",
      "Contributing_Factor_2": "Temperature calibration overdue by 2 days (due 2024-10-10, current date 2024-10-12). Inaccurate sensor feedback may have compounded the PID control error.",
      "Contributing_Factor_3": "No automated hard stop interlock on EQP_GRAN_01 for product bed temperature >75°C. The alarm activated but did not automatically halt the process — manual intervention required."
    },

    "Linked_Records": {
      "OOS_Reference": "OOS-2024-0048",
      "Equipment_Log_Reference": "EQL-EQP_GRAN_01-20241012",
      "Maintenance_Log_Reference": "MNT-EQP_GRAN_01-20240715",
      "BMR_Reference": "BMR-AURO-PARA-500-BTC0048",
      "LIMS_Sample_References": ["SAMP-BTC0048-001","SAMP-BTC0048-002"]
    },

    "Investigation_Timeline": {
      "Phase_1_Due": "2024-10-17",
      "Phase_2_Due": "2024-11-12",
      "CAPA_Due": "2024-12-12",
      "Effectiveness_Check_Due": "2025-03-12"
    },

    "Batch_Disposition": "HOLD — Pending investigation completion and QA Manager review",
    "Distribution_Status": "No product distributed. Batch quarantined at Unit III since 2024-10-12 08:35."
  }
}