customViews Collection

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Observation", "triggerType": "PARAMETER_VALUE", "orderTree": 1412}, {"_id": "413939244530810880", "type": "TEXT", "displayName": "6. SAP notification for breakdown initiated during batch processing are reviewed, assessed for its impact on batch and closed.", "triggerType": "PARAMETER_VALUE", "orderTree": 1413}, {"_id": "413939263463899136", "type": "TEXT", "displayName": "6. Observation", "triggerType": "PARAMETER_VALUE", "orderTree": 1414}, {"_id": "413939405055213568", "type": "TEXT", "displayName": "7. Verify any Critical and major alarm generated during Manufacturing / Packaging are acknowledged and addressed as per respective SOPs", "triggerType": "PARAMETER_VALUE", "orderTree": 1415}, {"_id": "413939246544076800", "type": "TEXT", "displayName": "7. Observation", "triggerType": "PARAMETER_VALUE", "orderTree": 1416}, {"_id": "413939251921174528", "type": "TEXT", "displayName": "8. Verify the availability of Alarm report for all equipment (as applicable). The report shall review by production and verify by QA after completion of batch", "triggerType": "PARAMETER_VALUE", "orderTree": 1417}, {"_id": "413939308686884864", "type": "TEXT", "displayName": "8. Observation", "triggerType": "PARAMETER_VALUE", "orderTree": 1418}, {"_id": "413939253783445504", "type": "TEXT", "displayName": "9. Verify any new alarm is generated", "triggerType": "PARAMETER_VALUE", "orderTree": 1419}, {"_id": "413939382250782720", "type": "TEXT", "displayName": "Type of New Alarm____________", "triggerType": "PARAMETER_VALUE", "orderTree": 1420}, {"_id": "413939342614609920", "type": "TEXT", "displayName": "9. Observation", "triggerType": "PARAMETER_VALUE", "orderTree": 1421}, {"_id": "413939324314861568", "type": "TEXT", "displayName": "10. Verify the completeness and availability for Audit trial review checklist for all applicable equipment.   ", "triggerType": "PARAMETER_VALUE", "orderTree": 1422}, {"_id": "413939231968870400", "type": "TEXT", "displayName": "10. Observation", "triggerType": "PARAMETER_VALUE", "orderTree": 1423}, {"_id": "413939248225992704", "type": "TEXT", "displayName": "11. Machine printout applicable for the batch shall be reviewed by production and verified by QA after completion of batch. If any parameter reading observed out of specified batch limit, then the same shall handle as per SOP “Deviation Management”, Ref. No:  THM/QA/071 R (current version of the SOP).", "triggerType": "PARAMETER_VALUE", "orderTree": 1424}, {"_id": "413939355197521920", "type": "TEXT", "displayName": "11. Observation", "triggerType": "PARAMETER_VALUE", "orderTree": 1425}, {"_id": "413939263254183936", "type": "TEXT", "displayName": "12. Any quality event reported during batch execution, decision on the batch disposition shall be updated in the final batch release activity based on the quality event outcome.", "triggerType": "PARAMETER_VALUE", "orderTree": 1426}, {"_id": "413939233030029312", "type": "TEXT", "displayName": "12. Observation", "triggerType": "PARAMETER_VALUE", "orderTree": 1427}, {"_id": "413939446868230144", "type": "TEXT", "displayName": "13. Any observation during the batch operation shall be updated in the EBMR observation section with assessment. EBMR review by production and QA shall complete by updating the observation section, if any. ", "triggerType": "PARAMETER_VALUE", "orderTree": 1428}, {"_id": "413939420322480128", "type": "TEXT", "displayName": "13. Observation", "triggerType": "PARAMETER_VALUE", "orderTree": 1429}, {"_id": "413939445110816768", "type": "TEXT", "displayName": "14. Any significant or unusual stoppage or discrepancy observed during manufacturing are recorded in the batch record.", "triggerType": "PARAMETER_VALUE", "orderTree": 1430}, {"_id": "413939331029942272", "type": "TEXT", "displayName": "14. Observation", "triggerType": "PARAMETER_VALUE", "orderTree": 1431}, {"_id": "413939449170903040", "type": "DATE", "displayName": "General | verification checklist by QA End", "triggerType": "TSK_END_TIME", "orderTree": 1432}, {"_id": "413939449170903040", "type": "TEXT", "displayName": "General | verification checklist by QA Ended By", "triggerType": "TSK_ENDED_BY", "orderTree": 1433}, {"_id": "413939423916998656", "type": "DATE", "displayName": "Suspension Preparation | verification checklist by QA Start", "triggerType": "TSK_START_TIME", "orderTree": 1434}, {"_id": "413939423916998656", "type": "TEXT", "displayName": "Suspension Preparation | verification checklist by QA Started By", "triggerType": "TSK_STARTED_BY", "orderTree": 1435}, {"_id": "413939316706394112", "type": "TEXT", "displayName": "1. Line clearance activities are carried out satisfactorily", "triggerType": "PARAMETER_VALUE", "orderTree": 1436}, {"_id": "413939235034906624", "type": "TEXT", "displayName": "1. Observation", "triggerType": "PARAMETER_VALUE", "orderTree": 1437}, {"_id": "413939272297103360", "type": "TEXT", "displayName": "2. In-process activities clearance activities are carried out satisfactorily.", "triggerType": "PARAMETER_VALUE", "orderTree": 1438}, {"_id": "413939430271369216", "type": "TEXT", "displayName": "2. Observation", "triggerType": "PARAMETER_VALUE", "orderTree": 1439}, {"_id": "413939281075781632", "type": "TEXT", "displayName": "3. Ensure the Cleaning Validation/verification results are reviewed as applicable.", "triggerType": "PARAMETER_VALUE", "orderTree": 1440}, {"_id": "413939389305602048", "type": "TEXT", "displayName": "3. Observation", "triggerType": "PARAMETER_VALUE", "orderTree": 1441}, {"_id": "413939265577828352", "type": "TEXT", "displayName": "4. All In-process samples are collected as per approved protocol or EBMR and results are complying, and quantity entered in the EBMR", "triggerType": "PARAMETER_VALUE", "orderTree": 1442}, {"_id": "413939293222486016", "type": "TEXT", "displayName": "4. Observation", "triggerType": "PARAMETER_VALUE", "orderTree": 1443}, {"_id": "413939296477265920", "type": "TEXT", "displayName": "5. Sieve integrity verification is satisfactory at processing stage before and after use", "triggerType": "PARAMETER_VALUE", "orderTree": 1444}, {"_id": "413939445152759808", "type": "TEXT", "displayName": "5. Observation", "triggerType": "PARAMETER_VALUE", "orderTree": 1445}, {"_id": "413939224326848512", "type": "TEXT", "displayName": "6. All Critical Control Points/Critical process parameters are complying", "triggerType": "PARAMETER_VALUE", "orderTree": 1446}, {"_id": "413939398172360704", "type": "TEXT", "displayName": "6. Observation", "triggerType": "PARAMETER_VALUE", "orderTree": 1447}, {"_id": "413939423916998656", "type": "DATE", "displayName": "Suspension Preparation | verification checklist by QA End", "triggerType": "TSK_END_TIME", "orderTree": 1448}, {"_id": "413939423916998656", "type": "TEXT", "displayName": "Suspension Preparation | verification checklist by QA Ended By", "triggerType": "TSK_ENDED_BY", "orderTree": 1449}, {"_id": "413939419852718080", "type": "DATE", "displayName": "General details | Line Clearance for Blister Forming Filling and Freezing machine  Start", "triggerType": "TSK_START_TIME", "orderTree": 1450}, {"_id": "413939419852718080", "type": "TEXT", "displayName": "General details | Line Clearance for Blister Forming Filling and Freezing machine  Started By", "triggerType": "TSK_STARTED_BY", "orderTree": 1451}, {"_id": "413939327527698432", "type": "TEXT", "displayName": "Swab / Rinse Report ", "triggerType": "PARAMETER_VALUE", "orderTree": 1452}, {"_id": "413939420494446592", "type": "TEXT", "displayName": "AR Number (if applicable)", "triggerType": "PARAMETER_VALUE", "orderTree": 1453}, {"_id": "413939372004098048", "type": "TEXT", "displayName": "Area [RDT Area]", "triggerType": "RESOURCE_PARAMETER", "orderTree": 1454}, {"_id": "413939239568949248", "type": "TEXT", "displayName": "Select the Blister forming, filling and freezing machine", "triggerType": "RESOURCE_PARAMETER", "orderTree": 1455}, {"_id": "413939322007994368", "type": "TEXT", "displayName": "Previous Product name", "triggerType": "PARAMETER_VALUE", "orderTree": 1456}, {"_id": "413939321760530432", "type": "TEXT", "displayName": "Previous Batch number", "triggerType": "PARAMETER_VALUE", "orderTree": 1457}, {"_id": "413939236276420608", "type": "FILE", "displayName": "Capture the RDU ", "triggerType": "PARAMETER_VALUE", "orderTree": 1458}, {"_id": "413939454728355840", "type": "TEXT", "displayName": "Relative Humidity %: (NMT 65 % RH)", "triggerType": "PARAMETER_VALUE", "orderTree": 1459}, {"_id": "413939298951905280", "type": "TEXT", "displayName": "Temperature: (NMT 25°C)", "triggerType": "PARAMETER_VALUE", "orderTree": 1460}, {"_id": "413939321244631040", "type": "TEXT", "displayName": "Differential pressure: (NLT 6 Pa)", "triggerType": "PARAMETER_VALUE", "orderTree": 1461}, {"_id": "413939252042809344", "type": "TEXT", "displayName": "Select the changeover type", "triggerType": "PARAMETER_VALUE", "orderTree": 1462}, {"_id": "413939374067695616", "type": "TEXT", "displayName": "Enter the JOB ID of checklist for changeover", "triggerType": "PARAMETER_VALUE", "orderTree": 1463}, {"_id": "413939254655860736", "type": "TEXT", "displayName": "Remarks (If any)", "triggerType": "PARAMETER_VALUE", "orderTree": 1464}, {"_id": "413939419852718080", "type": "DATE", "displayName": "General details | Line Clearance for Blister Forming Filling and Freezing machine  End", "triggerType": "TSK_END_TIME", "orderTree": 1465}, {"_id": "413939419852718080", "type": "TEXT", "displayName": "General details | Line Clearance for Blister Forming Filling and Freezing machine  Ended By", "triggerType": "TSK_ENDED_BY", "orderTree": 1466}, {"_id": "413939252999110656", "type": "DATE", "displayName": "1 | Line clearance for Blister Forming, Filling and Freezing machine by PR operator Start", "triggerType": "TSK_START_TIME", "orderTree": 1467}, {"_id": "413939252999110656", "type": "TEXT", "displayName": "1 | Line clearance for Blister Forming, Filling and Freezing machine by PR operator Started By", "triggerType": "TSK_STARTED_BY", "orderTree": 1468}, {"_id": "413939440610328576", "type": "TEXT", "displayName": "1. Status board updated", "triggerType": "PARAMETER_VALUE", "orderTree": 1469}, {"_id": "413939408825892864", "type": "TEXT", "displayName": "2. Area cleanliness for floor, walls, ceiling, utility lines, AHU grills, SS pallets, doors and light fixtures", "triggerType": "PARAMETER_VALUE", "orderTree": 1470}, {"_id": "413939355428208640", "type": "TEXT", "displayName": "3. Complete absence from previous product/labels", "triggerType": "PARAMETER_VALUE", "orderTree": 1471}, {"_id": "413939255998038016", "type": "TEXT", "displayName": "4. Waste/Reject bin cleaned", "triggerType": "PARAMETER_VALUE", "orderTree": 1472}, {"_id": "413939453738500096", "type": "TEXT", "displayName": "5. Completeness of Batch record up to relevant stage", "triggerType": "PARAMETER_VALUE", "orderTree": 1473}, {"_id": "413939280887037952", "type": "TEXT", "displayName": "6. No damage to floor, walls and equipment. ", "triggerType": "PARAMETER_VALUE", "orderTree": 1474}, {"_id": "413939438240546816", "type": "TEXT", "displayName": "7. Cleaning details updated in respective e-Log and labels", "triggerType": "PARAMETER_VALUE", "orderTree": 1475}, {"_id": "413939242563682304", "type": "TEXT", "displayName": "8. Ensure balance cleanliness and Calibration/Verification completed.", "triggerType": "PARAMETER_VALUE", "orderTree": 1476}, {"_id": "413939416509857792", "type": "TEXT", "displayName": "9. Environmental conditions within the limits ", "triggerType": "PARAMETER_VALUE", "orderTree": 1477}, {"_id": "413939316777697280", "type": "TEXT", "displayName": "10. Utility points and toolboxes are cleaned.", "triggerType": "PARAMETER_VALUE", "orderTree": 1478}, {"_id": "413939314756042752", "type": "TEXT", "displayName": "11. Ensure cleaning validity of the Equipment’s/Accessories within the due date", "triggerType": "PARAMETER_VALUE", "orderTree": 1479}, {"_id": "413939362390753280", "type": "TEXT", "displayName": "12. Unused fixed equipment’s/machines in same area cleaned, labelled/stretch wrapped.", "triggerType": "PARAMETER_VALUE", "orderTree": 1480}, {"_id": "413939250713214976", "type": "TEXT", "displayName": "13. Swab results if any", "triggerType": "PARAMETER_VALUE", "orderTree": 1481}, {"_id": "413939309022429184", "type": "TEXT", "displayName": "13. Observation", "triggerType": "PARAMETER_VALUE", "orderTree": 1482}, {"_id": "413939431978450944", "type": "TEXT", "displayName": "14. Check and ensure that all instruments/ Equipment’s used in the manufacturing/ packing are in the valid calibrated/ qualified state and Preventive maintenance due date.", "triggerType": "PARAMETER_VALUE", "orderTree": 1483}, {"_id": "413939242089725952", "type": "TEXT", "displayName": "15. Check and ensure that the Drain point in the area shall be cleaned and filled with the respective sanitized solution of that week. (If applicable).", "triggerType": "PARAMETER_VALUE", "orderTree": 1484}, {"_id": "413939444439728128", "type": "TEXT", "displayName": "15. Observation", "triggerType": "PARAMETER_VALUE", "orderTree": 1485}, {"_id": "413939299358752768", "type": "TEXT", "displayName": "16. Check and ensure that previous Batch/ Product Documents shall be removed from the respective area.", "triggerType": "PARAMETER_VALUE", "orderTree": 1486}, {"_id": "413939327821299712", "type": "TEXT", "displayName": "17. Ensure the adequate light shall be present in the area.", "triggerType": "PARAMETER_VALUE", "orderTree": 1487}, {"_id": "413939301237800960", "type": "TEXT", "displayName": "Remarks", "triggerType": "PARAMETER_VALUE", "orderTree": 1488}, {"_id": "413939400768634880", "type": "TEXT", "displayName": "Select the Blister Filling and Freezing Machine ID:", "triggerType": "RESOURCE_PARAMETER", "orderTree": 1489}, {"_id": "413939371077156864", "type": "TEXT", "displayName": "a. Machine outer surface and bottom ", "triggerType": "PARAMETER_VALUE", "orderTree": 1490}, {"_id": "413939279196733440", "type": "TEXT", "displayName": "b. Guide track", "triggerType": "PARAMETER_VALUE", "orderTree": 1491}, {"_id": "413939324298084352", "type": "TEXT", "displayName": "c. Filling assembly and base plate", "triggerType": "PARAMETER_VALUE", "orderTree": 1492}, {"_id": "413939430372032512", "type": "TEXT", "displayName": "d. Blister loading tray", "triggerType": "PARAMETER_VALUE", "orderTree": 1493}, {"_id": "413939432980889600", "type": "TEXT", "displayName": "e. Filling needles", "triggerType": "PARAMETER_VALUE", "orderTree": 1494}, {"_id": "413939403914362880", "type": "TEXT", "displayName": "f. Integrity of the gaskets", "triggerType": "PARAMETER_VALUE", "orderTree": 1495}, {"_id": "413939403469766656", "type": "TEXT", "displayName": "g. Quick freezing tunnel tray", "triggerType": "PARAMETER_VALUE", "orderTree": 1496}, {"_id": "413939439402369024", "type": "TEXT", "displayName": "h. Tubing’s", "triggerType": "PARAMETER_VALUE", "orderTree": 1497}, {"_id": "413939275237310464", "type": "TEXT", "displayName": "i. Needle holder and tray", "triggerType": "PARAMETER_VALUE", "orderTree": 1498}, {"_id": "413939238008668160", "type": "TEXT", "displayName": "j. Connectors", "triggerType": "PARAMETER_VALUE", "orderTree": 1499}, {"_id": "413939284200538112", "type": "TEXT", "displayName": "h. Correct change parts /tubing’s are fixed as per batch record", "triggerType": "PARAMETER_VALUE", "orderTree": 1500}, {"_id": "413939322721026048", "type": "TEXT", "displayName": "Select the Dosing Tank ID No.:", "triggerType": "RESOURCE_PARAMETER", "orderTree": 1501}, {"_id": "413939257164054528", "type": "TEXT", "displayName": "a. Dosing tank inner side ", "triggerType": "PARAMETER_VALUE", "orderTree": 1502}, {"_id": "413939356699082752", "type": "TEXT", "displayName": "b. View glass and gasket", "triggerType": "PARAMETER_VALUE", "orderTree": 1503}, {"_id": "413939219050414080", "type": "TEXT", "displayName": "c. Side walls across glass lining", "triggerType": "PARAMETER_VALUE", "orderTree": 1504}, {"_id": "413939370783555584", "type": "TEXT", "displayName": "d. Bottom and side walls", "triggerType": "PARAMETER_VALUE", "orderTree": 1505}, {"_id": "413939222879813632", "type": "TEXT", "displayName": "Select the Stirrer ID No:", "triggerType": "RESOURCE_PARAMETER", "orderTree": 1506}, {"_id": "413939459476307968", "type": "TEXT", "displayName": "a.\tStirrer shaft", "triggerType": "PARAMETER_VALUE", "orderTree": 1507}, {"_id": "413939278919909376", "type": "TEXT", "displayName": "b.\tSurface", "triggerType": "PARAMETER_VALUE", "orderTree": 1508}, {"_id": "413939227854258176", "type": "TEXT", "displayName": "c.\tMixing blade", "triggerType": "PARAMETER_VALUE", "orderTree": 1509}, {"_id": "413939234305097728", "type": "TEXT", "displayName": "d.\tStand", "triggerType": "PARAMETER_VALUE", "orderTree": 1510}, {"_id": "413939231213895680", "type": "TEXT", "displayName": "Select the Homogenizer ID No:", "triggerType": "RESOURCE_PARAMETER", "orderTree": 1511}, {"_id": "413939453088382976", "type": "TEXT", "displayName": "a. Head", "triggerType": "PARAMETER_VALUE", "orderTree": 1512}, {"_id": "413939336662892544", "type": "TEXT", "displayName": "b. Shaft", "triggerType": "PARAMETER_VALUE", "orderTree": 1513}, {"_id": "413939240856600576", "type": "TEXT", "displayName": "c. Rotor", "triggerType": "PARAMETER_VALUE", "orderTree": 1514}, {"_id": "413939404849692672", "type": "TEXT", "displayName": "d. Stator", "triggerType": "PARAMETER_VALUE", "orderTree": 1515}, {"_id": "413939374491320320", "type": "TEXT", "displayName": "e. Ring", "triggerType": "PARAMETER_VALUE", "orderTree": 1516}, {"_id": "413939217435607040", "type": "TEXT", "displayName": "f. Stand", "triggerType": "PARAMETER_VALUE", "orderTree": 1517}, {"_id": "413939439461089280", "type": "TEXT", "displayName": "Select the Spatula ID", "triggerType": "RESOURCE_PARAMETER", "orderTree": 1518}, {"_id": "413939295625822208", "type": "TEXT", "displayName": "a.\tSpatula top side", "triggerType": "PARAMETER_VALUE", "orderTree": 1519}, {"_id": "413939326093246464", "type": "TEXT", "displayName": "b. Bottom side", "triggerType": "PARAMETER_VALUE", "orderTree": 1520}, {"_id": "413939386872905728", "type": "TEXT", "displayName": "Spatula | 2", "triggerType": "PARAMETER_VALUE", "orderTree": 1521}, {"_id": "413939413401878528", "type": "TEXT", "displayName": "Select the Spatula ID:", "triggerType": "RESOURCE_PARAMETER", "orderTree": 1522}, {"_id": "413939323375337472", "type": "TEXT", "displayName": "a.\tSpatula top side", "triggerType": "PARAMETER_VALUE", "orderTree": 1523}, {"_id": "413939251027787776", "type": "TEXT", "displayName": "b. Bottom side", "triggerType": "PARAMETER_VALUE", "orderTree": 1524}, {"_id": "413939252999110656", "type": "DATE", "displayName": "1 | Line clearance for Blister Forming, Filling and Freezing machine by PR operator End", "triggerType": "TSK_END_TIME", "orderTree": 1525}, {"_id": "413939252999110656", "type": "TEXT", "displayName": "1 | Line clearance for Blister Forming, Filling and Freezing machine by PR operator Ended By", "triggerType": "TSK_ENDED_BY", "orderTree": 1526}, {"_id": "413939306610704384", "type": "DATE", "displayName": "IPQA | Area and equipment clearing for manufacturing (1) Start", "triggerType": "TSK_START_TIME", "orderTree": 1527}, {"_id": "413939306610704384", "type": "TEXT", "displayName": "IPQA | Area and equipment clearing for manufacturing (1) Started By", "triggerType": "TSK_STARTED_BY", "orderTree": 1528}, {"_id": "413939437980499968", "type": "TEXT", "displayName": "IPQA | Area and equipment’s cleared for Manufacturing                                   ", "triggerType": "PARAMETER_VALUE", "orderTree": 1529}, {"_id": "413939421761126400", "type": "TEXT", "displayName": "IPQA | Is additional Line clearance required", "triggerType": "PARAMETER_VALUE", "orderTree": 1530}, {"_id": "413939367168065536", "type": "TEXT", "displayName": "Remarks", "triggerType": "PARAMETER_VALUE", "orderTree": 1531}, {"_id": "413939306610704384", "type": "DATE", "displayName": "IPQA | Area and equipment clearing for manufacturing (1) End", "triggerType": "TSK_END_TIME", "orderTree": 1532}, {"_id": "413939306610704384", "type": "TEXT", "displayName": "IPQA | Area and equipment clearing for manufacturing (1) Ended By", "triggerType": "TSK_ENDED_BY", "orderTree": 1533}, {"_id": "413939327968100352", "type": "DATE", "displayName": "2 | Line clearance for Blister Forming, Filling and Freezing machine by PR operator Start", "triggerType": "TSK_START_TIME", "orderTree": 1534}, {"_id": "413939327968100352", "type": "TEXT", "displayName": "2 | Line clearance for Blister Forming, Filling and Freezing machine by PR operator Started By", "triggerType": "TSK_STARTED_BY", "orderTree": 1535}, {"_id": "413939279024766976", "type": "TEXT", "displayName": "1. Status board updated", "triggerType": "PARAMETER_VALUE", "orderTree": 1536}, {"_id": "413939426391638016", "type": "TEXT", "displayName": "2. Area cleanliness for floor, walls, ceiling, utility lines, AHU grills, SS pallets, doors and light fixtures", "triggerType": "PARAMETER_VALUE", "orderTree": 1537}, {"_id": "413939358464884736", "type": "TEXT", "displayName": "3. Complete absence from previous product/labels", "triggerType": "PARAMETER_VALUE", "orderTree": 1538}, {"_id": "413939346607587328", "type": "TEXT", "displayName": "4. Waste / Reject bin cleaned", "triggerType": "PARAMETER_VALUE", "orderTree": 1539}, {"_id": "413939297836220416", "type": "TEXT", "displayName": "5. Completeness of Batch record up to relevant stage", "triggerType": "PARAMETER_VALUE", "orderTree": 1540}, {"_id": "413939424814579712", "type": "TEXT", "displayName": "6. No damage to floor, walls and equipment", "triggerType": "PARAMETER_VALUE", "orderTree": 1541}, {"_id": "413939272464875520", "type": "TEXT", "displayName": "7. Cleaning details updated in respective logbooks and labels", "triggerType": "PARAMETER_VALUE", "orderTree": 1542}, {"_id": "413939315569737728", "type": "TEXT", "displayName": "8. Ensure balance cleanliness and Calibration/Verification completed", "triggerType": "PARAMETER_VALUE", "orderTree": 1543}, {"_id": "413939243457069056", "type": "TEXT", "displayName": "9. Environmental conditions within the limits ", "triggerType": "PARAMETER_VALUE", "orderTree": 1544}, {"_id": "413939352785797120", "type": "TEXT", "displayName": "10. Utility points and toolboxes are cleaned", "triggerType": "PARAMETER_VALUE", "orderTree": 1545}, {"_id": "413939385056772096", "type": "TEXT", "displayName": "11. 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Line clearance activities are carried out satisfactorily", "triggerType": "PARAMETER_VALUE", "orderTree": 4695}, {"_id": "413939255280812032", "type": "TEXT", "displayName": "1. Observation", "triggerType": "PARAMETER_VALUE", "orderTree": 4696}, {"_id": "413939308900794368", "type": "TEXT", "displayName": "2. Startup checks and in process activities are carried out as per the defined frequency and results are found satisfactory.", "triggerType": "PARAMETER_VALUE", "orderTree": 4697}, {"_id": "413939306119970816", "type": "TEXT", "displayName": "2. Observation", "triggerType": "PARAMETER_VALUE", "orderTree": 4698}, {"_id": "413939293813882880", "type": "TEXT", "displayName": "3. Ensure the Cleaning Validation/verification results are reviewed as applicable", "triggerType": "PARAMETER_VALUE", "orderTree": 4699}, {"_id": "413939316685422592", "type": "TEXT", "displayName": "3. Observation", "triggerType": "PARAMETER_VALUE", "orderTree": 4700}, {"_id": "413939431122812928", "type": "TEXT", "displayName": "4. Filling activity is done within the hold time of suspension.", "triggerType": "PARAMETER_VALUE", "orderTree": 4701}, {"_id": "413939457832140800", "type": "TEXT", "displayName": "4. Observation", "triggerType": "PARAMETER_VALUE", "orderTree": 4702}, {"_id": "413939353775652864", "type": "TEXT", "displayName": "5. Verify filling is done within the hold time of suspension", "triggerType": "PARAMETER_VALUE", "orderTree": 4703}, {"_id": "413939272443904000", "type": "TEXT", "displayName": "5. Observation", "triggerType": "PARAMETER_VALUE", "orderTree": 4704}, {"_id": "413939446142615552", "type": "TEXT", "displayName": "6. Verify the audit trial for compliance as applicable", "triggerType": "PARAMETER_VALUE", "orderTree": 4705}, {"_id": "413939350680256512", "type": "TEXT", "displayName": "6. Observation", "triggerType": "PARAMETER_VALUE", "orderTree": 4706}, {"_id": "413939316517650432", "type": "TEXT", "displayName": "7. Review the equipment/process printouts i.e., Filling machine calibration, lyophilization history data etc. for correctness and completeness by comparing the same with the requirements/acceptance criteria as stated under relevant sections mentioned in the EBMR and duly signed by Manufacturing and QA personnel. ", "triggerType": "PARAMETER_VALUE", "orderTree": 4707}, {"_id": "413939280333389824", "type": "TEXT", "displayName": "7. Observation", "triggerType": "PARAMETER_VALUE", "orderTree": 4708}, {"_id": "413939445970649088", "type": "TEXT", "displayName": "8. All in-process samples are withdrawn as per EBMR or Process Validation Protocol and sample quantity updated in EBMR.", "triggerType": "PARAMETER_VALUE", "orderTree": 4709}, {"_id": "413939224725307392", "type": "TEXT", "displayName": "8. Observation", "triggerType": "PARAMETER_VALUE", "orderTree": 4710}, {"_id": "413939459925098496", "type": "TEXT", "displayName": "9.The priming activity performed as per EBMR instruction after process stoppages if any", "triggerType": "PARAMETER_VALUE", "orderTree": 4711}, {"_id": "413939316643479552", "type": "TEXT", "displayName": "Remarks", "triggerType": "PARAMETER_VALUE", "orderTree": 4712}, {"_id": "413939347052183552", "type": "TEXT", "displayName": "9. Observation", "triggerType": "PARAMETER_VALUE", "orderTree": 4713}, {"_id": "413939361992294400", "type": "TEXT", "displayName": "10. All types of rejects generated during blister filling and freezing activity shall be recorded in EBMR and the details of all Reject labels shall be attached in the annexure for affixing labels, Prints and Specimens (as per THM/QA/018) and all the attachments shall be scanned and upload in the EBMPR and hard copy of all attachment shall be archived and submitted to document cell.", "triggerType": "PARAMETER_VALUE", "orderTree": 4714}, {"_id": "413939225333481472", "type": "TEXT", "displayName": "10. Observation", "triggerType": "PARAMETER_VALUE", "orderTree": 4715}, {"_id": "413939262142693376", "type": "TEXT", "displayName": "11. Summary of rejected suspension quantity and updated in EBMR", "triggerType": "PARAMETER_VALUE", "orderTree": 4716}, {"_id": "413939416706990080", "type": "TEXT", "displayName": "11. Observation", "triggerType": "PARAMETER_VALUE", "orderTree": 4717}, {"_id": "413939219696336896", "type": "TEXT", "displayName": "12. Yield of bulk Suspension and after calibration and filling and yield found to be in limit", "triggerType": "PARAMETER_VALUE", "orderTree": 4718}, {"_id": "413939341209518080", "type": "TEXT", "displayName": "12. Observation", "triggerType": "PARAMETER_VALUE", "orderTree": 4719}, {"_id": "413939433572286464", "type": "TEXT", "displayName": "13. Reconciliation of primary packing material (Plain base foil) and material return details if any", "triggerType": "PARAMETER_VALUE", "orderTree": 4720}, {"_id": "413939410444894208", "type": "TEXT", "displayName": "13. Observation", "triggerType": "PARAMETER_VALUE", "orderTree": 4721}, {"_id": "413939334674792448", "type": "DATE", "displayName": "Blister Forming, filing, and freezing and Lyophilization | Verification checklist by QA End", "triggerType": "TSK_END_TIME", "orderTree": 4722}, {"_id": "413939334674792448", "type": "TEXT", "displayName": "Blister Forming, filing, and freezing and Lyophilization | Verification checklist by QA Ended By", "triggerType": "TSK_ENDED_BY", "orderTree": 4723}, {"_id": "413939222514909184", "type": "DATE", "displayName": "General details Start", "triggerType": "TSK_START_TIME", "orderTree": 4724}, {"_id": "413939222514909184", "type": "TEXT", "displayName": "General details Started By", "triggerType": "TSK_STARTED_BY", "orderTree": 4725}, {"_id": "413939394133245952", "type": "FILE", "displayName": "Capture the RDU", "triggerType": "PARAMETER_VALUE", "orderTree": 4726}, {"_id": "413939294128455680", "type": "TEXT", "displayName": "Relative Humidity (RH)", "triggerType": "PARAMETER_VALUE", "orderTree": 4727}, {"_id": "413939248595091456", "type": "TEXT", "displayName": "Temperature (°C)", "triggerType": "PARAMETER_VALUE", "orderTree": 4728}, {"_id": "413939374780727296", "type": "TEXT", "displayName": "Differential Pressure ", "triggerType": "PARAMETER_VALUE", "orderTree": 4729}, {"_id": "413939269478531072", "type": "TEXT", "displayName": "Select the Area", "triggerType": "RESOURCE_PARAMETER", "orderTree": 4730}, {"_id": "413939367734296576", "type": "TEXT", "displayName": "Previous product name", "triggerType": "PARAMETER_VALUE", "orderTree": 4731}, {"_id": "413939329381580800", "type": "TEXT", "displayName": "Select the Changeover type", "triggerType": "PARAMETER_VALUE", "orderTree": 4732}, {"_id": "413939266114699264", "type": "TEXT", "displayName": "Previous batch number", "triggerType": "PARAMETER_VALUE", "orderTree": 4733}, {"_id": "413939223991304192", "type": "TEXT", "displayName": "Enter the JOB ID of checklist for changeover", "triggerType": "PARAMETER_VALUE", "orderTree": 4734}, {"_id": "413939222514909184", "type": "DATE", "displayName": "General details End", "triggerType": "TSK_END_TIME", "orderTree": 4735}, {"_id": "413939222514909184", "type": "TEXT", "displayName": "General details Ended By", "triggerType": "TSK_ENDED_BY", "orderTree": 4736}, {"_id": "413939405373980672", "type": "DATE", "displayName": "1 | Line clearance for Visual inspection by PR operator Start", "triggerType": "TSK_START_TIME", "orderTree": 4737}, {"_id": "413939405373980672", "type": "TEXT", "displayName": "1 | Line clearance for Visual inspection by PR operator Started By", "triggerType": "TSK_STARTED_BY", "orderTree": 4738}, {"_id": "413939271537934336", "type": "TEXT", "displayName": "1. Verify Status board of the area and equipment is updated", "triggerType": "PARAMETER_VALUE", "orderTree": 4739}, {"_id": "413939250432196608", "type": "TEXT", "displayName": "2. Area cleanliness for floor, walls, ceiling, utility lines, AHU grills, SS pallets, doors and light fixtures", "triggerType": "PARAMETER_VALUE", "orderTree": 4740}, {"_id": "413939410423922688", "type": "TEXT", "displayName": "3. Complete absence from previous product/labels", "triggerType": "PARAMETER_VALUE", "orderTree": 4741}, {"_id": "413939431710015488", "type": "TEXT", "displayName": "4. Ensure Inspection area is free from any cleaned or uncleaned Containers/Equipment’s/Accessories.", "triggerType": "PARAMETER_VALUE", "orderTree": 4742}, {"_id": "413939317851439104", "type": "TEXT", "displayName": "5. Completeness of Batch record up to relevant stage", "triggerType": "PARAMETER_VALUE", "orderTree": 4743}, {"_id": "413939436759957504", "type": "TEXT", "displayName": "6. No damage to floor, walls and equipment. ", "triggerType": "PARAMETER_VALUE", "orderTree": 4744}, {"_id": "413939262570512384", "type": "TEXT", "displayName": "7. Cleaning details updated in respective logbooks and labels", "triggerType": "PARAMETER_VALUE", "orderTree": 4745}, {"_id": "413939309274087424", "type": "TEXT", "displayName": "8. Environmental conditions within the limits ", "triggerType": "PARAMETER_VALUE", "orderTree": 4746}, {"_id": "413939279385477120", "type": "TEXT", "displayName": "9. Ensure cleaning validity of the Equipment’s/Accessories within the due date", "triggerType": "PARAMETER_VALUE", "orderTree": 4747}, {"_id": "413939421094232064", "type": "TEXT", "displayName": "10. Check and ensure that the Drain point in the area shall be cleaned and filled with the respective sanitized solution of that week. (If applicable).", "triggerType": "PARAMETER_VALUE", "orderTree": 4748}, {"_id": "413939421010345984", "type": "TEXT", "displayName": "10. Observation", "triggerType": "PARAMETER_VALUE", "orderTree": 4749}, {"_id": "413939452861890560", "type": "TEXT", "displayName": "11. Ensure qualified visual inspectors are performing in inspection activity", "triggerType": "PARAMETER_VALUE", "orderTree": 4750}, {"_id": "413939349770092544", "type": "TEXT", "displayName": "12. Check and ensure that all instruments/ Equipment’s used in the manufacturing/ packing are in the valid calibrated/ qualified state and Preventive maintenance due date.", "triggerType": "PARAMETER_VALUE", "orderTree": 4751}, {"_id": "413939234200240128", "type": "TEXT", "displayName": "13. Check and ensure that previous Batch/ Product Documents shall be removed from the respective area.", "triggerType": "PARAMETER_VALUE", "orderTree": 4752}, {"_id": "413939415171874816", "type": "TEXT", "displayName": "14. Ensure the adequate light shall be present in the area.", "triggerType": "PARAMETER_VALUE", "orderTree": 4753}, {"_id": "413939223676731392", "type": "TEXT", "displayName": "Select the Inspection Table ID                                              ", "triggerType": "RESOURCE_PARAMETER", "orderTree": 4754}, {"_id": "413939352227954688", "type": "TEXT", "displayName": "Enter the LUX Meter ID No.", "triggerType": "PARAMETER_VALUE", "orderTree": 4755}, {"_id": "413939284854849536", "type": "TEXT", "displayName": "Calibration Due for LUX meter", "triggerType": "PARAMETER_VALUE", "orderTree": 4756}, {"_id": "413939428547510272", "type": "TEXT", "displayName": "a.\tCleanliness of the Inspection table outer surface and bottom", "triggerType": "PARAMETER_VALUE", "orderTree": 4757}, {"_id": "413939288474533888", "type": "TEXT", "displayName": "b. Cleanliness of Upper shelf and lower shelf", "triggerType": "PARAMETER_VALUE", "orderTree": 4758}, {"_id": "413939223634788352", "type": "TEXT", "displayName": "c. Cleanliness of trolley and its wheels are free from rust, dust, any damages or stains.", "triggerType": "PARAMETER_VALUE", "orderTree": 4759}, {"_id": "413939293495115776", "type": "TEXT", "displayName": "d.\tEnsure working condition of the lights", "triggerType": "PARAMETER_VALUE", "orderTree": 4760}, {"_id": "413939434327261184", "type": "TEXT", "displayName": "e.\tEnsure validity period of LUX meter within the due date.", "triggerType": "PARAMETER_VALUE", "orderTree": 4761}, {"_id": "413939377955815424", "type": "TEXT", "displayName": "f. Verify the light intensity at four corners and at center and record the details below.  Limit: NLT 500 LUX", "triggerType": "PARAMETER_VALUE", "orderTree": 4762}, {"_id": "413939233671757824", "type": "FILE", "displayName": "Capture the value in LUX meter | Right: Front", "triggerType": "PARAMETER_VALUE", "orderTree": 4763}, {"_id": "413939216051486720", "type": "TEXT", "displayName": "Right | Front", "triggerType": "PARAMETER_VALUE", "orderTree": 4764}, {"_id": "413939289124651008", "type": "FILE", "displayName": "Capture the value in LUX meter | Right: Rear", "triggerType": "PARAMETER_VALUE", "orderTree": 4765}, {"_id": "413939321987022848", "type": "TEXT", "displayName": "Right | Rear", "triggerType": "PARAMETER_VALUE", "orderTree": 4766}, {"_id": "413939386650607616", "type": "FILE", "displayName": "Capture the value in LUX meter | Center", "triggerType": "PARAMETER_VALUE", "orderTree": 4767}, {"_id": "413939334397968384", "type": "TEXT", "displayName": "Center", "triggerType": "PARAMETER_VALUE", "orderTree": 4768}, {"_id": "413939367381975040", "type": "FILE", "displayName": "Capture the value in LUX meter | Left: Front", "triggerType": "PARAMETER_VALUE", "orderTree": 4769}, {"_id": "413939400277901312", "type": "TEXT", "displayName": "Left | Front", "triggerType": "PARAMETER_VALUE", "orderTree": 4770}, {"_id": "413939396163289088", "type": "FILE", "displayName": "Capture the value in LUX meter | Left: Rear", "triggerType": "PARAMETER_VALUE", "orderTree": 4771}, {"_id": "413939249471700992", "type": "TEXT", "displayName": "Left | Rear", "triggerType": "PARAMETER_VALUE", "orderTree": 4772}, {"_id": "413939344267165696", "type": "TEXT", "displayName": "Remarks (If Any)", "triggerType": "PARAMETER_VALUE", "orderTree": 4773}, {"_id": "413939405373980672", "type": "DATE", "displayName": "1 | Line clearance for Visual inspection by PR operator End", "triggerType": "TSK_END_TIME", "orderTree": 4774}, {"_id": "413939405373980672", "type": "TEXT", "displayName": "1 | Line clearance for Visual inspection by PR operator Ended By", "triggerType": "TSK_ENDED_BY", "orderTree": 4775}, {"_id": "413939458830385152", "type": "DATE", "displayName": "IPQA | Area and equipment clearing for Visual inspection (1) Start", "triggerType": "TSK_START_TIME", "orderTree": 4776}, {"_id": "413939458830385152", "type": "TEXT", "displayName": "IPQA | Area and equipment clearing for Visual inspection (1) Started By", "triggerType": "TSK_STARTED_BY", "orderTree": 4777}, {"_id": "413939313053155328", "type": "TEXT", "displayName": "IPQA | Area and equipment’s allowed for Inspection", "triggerType": "PARAMETER_VALUE", "orderTree": 4778}, {"_id": "413939346842468352", "type": "TEXT", "displayName": "IPQA | Is additional Line clearance required", "triggerType": "PARAMETER_VALUE", "orderTree": 4779}, {"_id": "413939256333582336", "type": "TEXT", "displayName": "Remarks", "triggerType": "PARAMETER_VALUE", "orderTree": 4780}, {"_id": "413939458830385152", "type": "DATE", "displayName": "IPQA | Area and equipment clearing for Visual inspection (1) End", "triggerType": "TSK_END_TIME", "orderTree": 4781}, {"_id": "413939458830385152", "type": "TEXT", "displayName": "IPQA | Area and equipment clearing for Visual inspection (1) Ended By", "triggerType": "TSK_ENDED_BY", "orderTree": 4782}, {"_id": "413939390970740736", "type": "DATE", "displayName": "2 | Line clearance for Visual inspection by PR operator Start", "triggerType": "TSK_START_TIME", "orderTree": 4783}, {"_id": "413939390970740736", "type": "TEXT", "displayName": "2 | Line clearance for Visual inspection by PR operator Started By", "triggerType": "TSK_STARTED_BY", "orderTree": 4784}, {"_id": "413939310557544448", "type": "TEXT", "displayName": "1. Verify Status board of the area and equipment is updated", "triggerType": "PARAMETER_VALUE", "orderTree": 4785}, {"_id": "413939363133145088", "type": "TEXT", "displayName": "2. Area cleanliness for floor, walls, ceiling, utility lines, AHU grills, SS pallets, doors and light fixtures", "triggerType": "PARAMETER_VALUE", "orderTree": 4786}, {"_id": "413939448470454272", "type": "TEXT", "displayName": "3. Complete absence from previous product/labels", "triggerType": "PARAMETER_VALUE", "orderTree": 4787}, {"_id": "413939351535894528", "type": "TEXT", "displayName": "4. Ensure Inspection area is free from any cleaned or uncleaned Containers/Equipment’s/Accessories.", "triggerType": "PARAMETER_VALUE", "orderTree": 4788}, {"_id": "413939346439815168", "type": "TEXT", "displayName": "5. Completeness of Batch record up to relevant stage", "triggerType": "PARAMETER_VALUE", "orderTree": 4789}, {"_id": "413939334502825984", "type": "TEXT", "displayName": "6. No damage to floor, walls and equipment. ", "triggerType": "PARAMETER_VALUE", "orderTree": 4790}, {"_id": "413939453633642496", "type": "TEXT", "displayName": "7. Cleaning details updated in respective logbooks and labels", "triggerType": "PARAMETER_VALUE", "orderTree": 4791}, {"_id": "413939428866277376", "type": "TEXT", "displayName": "8. Environmental conditions within the limits ", "triggerType": "PARAMETER_VALUE", "orderTree": 4792}, {"_id": "413939315276136448", "type": "TEXT", "displayName": "9. Ensure cleaning validity of the Equipment’s/Accessories within the due date", "triggerType": "PARAMETER_VALUE", "orderTree": 4793}, {"_id": "413939311929081856", "type": "TEXT", "displayName": "10. Check and ensure that the Drain point in the area shall be cleaned and filled with the respective sanitized solution of that week. (If applicable).", "triggerType": "PARAMETER_VALUE", "orderTree": 4794}, {"_id": "413939233818558464", "type": "TEXT", "displayName": "10. Observation", "triggerType": "PARAMETER_VALUE", "orderTree": 4795}, {"_id": "413939237706678272", "type": "TEXT", "displayName": "11. Ensure qualified visual inspectors are performing in inspection activity", "triggerType": "PARAMETER_VALUE", "orderTree": 4796}, {"_id": "413939279918153728", "type": "TEXT", "displayName": "12. Check and ensure that all instruments/ Equipment’s used in the manufacturing/ packing are in the valid calibrated/ qualified state and Preventive maintenance due date.", "triggerType": "PARAMETER_VALUE", "orderTree": 4797}, {"_id": "413939297047691264", "type": "TEXT", "displayName": "13. Check and ensure that previous Batch/ Product Documents shall be removed from the respective area.", "triggerType": "PARAMETER_VALUE", "orderTree": 4798}, {"_id": "413939422436409344", "type": "TEXT", "displayName": "14. Ensure the adequate light shall be present in the area.", "triggerType": "PARAMETER_VALUE", "orderTree": 4799}, {"_id": "413939395194404864", "type": "TEXT", "displayName": "Select the Inspection Table ID                                                ", "triggerType": "RESOURCE_PARAMETER", "orderTree": 4800}, {"_id": "413939266475409408", "type": "TEXT", "displayName": "Enter the LUX Meter ID No.", "triggerType": "PARAMETER_VALUE", "orderTree": 4801}, {"_id": "413939254546808832", "type": "TEXT", "displayName": "Calibration Due for LUX meter", "triggerType": "PARAMETER_VALUE", "orderTree": 4802}, {"_id": "413939338856513536", "type": "TEXT", "displayName": "a.\tCleanliness of the Inspection table outer surface and bottom", "triggerType": "PARAMETER_VALUE", "orderTree": 4803}, {"_id": "413939235877961728", "type": "TEXT", "displayName": "b.\tCleanliness of Upper shelf and lower shelf", "triggerType": "PARAMETER_VALUE", "orderTree": 4804}, {"_id": "413939366878658560", "type": "TEXT", "displayName": "c. Cleanliness of trolley and its wheels are free from rust, dust, any damages or stains.", "triggerType": "PARAMETER_VALUE", "orderTree": 4805}, {"_id": "413939218366742528", "type": "TEXT", "displayName": "d.\tEnsure working condition of the lights", "triggerType": "PARAMETER_VALUE", "orderTree": 4806}, {"_id": "413939235475308544", "type": "TEXT", "displayName": "e.\tEnsure validity period of LUX meter within the due date.", "triggerType": "PARAMETER_VALUE", "orderTree": 4807}, {"_id": "413939241800318976", "type": "FILE", "displayName": "Capture the value in LUX meter | Right: Front", "triggerType": "PARAMETER_VALUE", "orderTree": 4808}, {"_id": "413939441096867840", "type": "TEXT", "displayName": "Right | Front ", "triggerType": "PARAMETER_VALUE", "orderTree": 4809}, {"_id": "413939379172163584", "type": "FILE", "displayName": "Capture the value in LUX meter | Right: Rear", "triggerType": "PARAMETER_VALUE", "orderTree": 4810}, {"_id": "413939340387434496", "type": "TEXT", "displayName": "Right | Rear", "triggerType": "PARAMETER_VALUE", "orderTree": 4811}, {"_id": "413939221491499008", "type": "FILE", "displayName": "Capture the value in LUX meter | Center", "triggerType": "PARAMETER_VALUE", "orderTree": 4812}, {"_id": "413939235513057280", "type": "TEXT", "displayName": "Center", "triggerType": "PARAMETER_VALUE", "orderTree": 4813}, {"_id": "413939342635581440", "type": "FILE", "displayName": "Capture the value in LUX meter | Left: Front", "triggerType": "PARAMETER_VALUE", "orderTree": 4814}, {"_id": "413939282908692480", "type": "TEXT", "displayName": "Left | Front", "triggerType": "PARAMETER_VALUE", "orderTree": 4815}, {"_id": "413939257633816576", "type": "FILE", "displayName": "Capture the value in LUX meter | Left: Rear", "triggerType": "PARAMETER_VALUE", "orderTree": 4816}, {"_id": "413939312969269248", "type": "TEXT", "displayName": "Left | Rear", "triggerType": "PARAMETER_VALUE", "orderTree": 4817}, {"_id": "413939435501666304", "type": "TEXT", 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