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Check List for New Equipment Qualification's |
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Sr. No |
List of Documents and activities |
Date |
Remarks (Reason for Not applicable) |
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1 |
URS |
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2 |
Vendor DQ |
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3 |
PO |
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4 |
FAT SAT & DQ report |
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5 |
Risk Assessment |
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6 |
Risk Assessment ID Allotment and Approval |
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7 |
Change Control initiation date with CCR No. |
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8 |
Change Control approved Date |
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9 |
Civil Works for Equipment Movement |
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10 |
Impacted AHU's Re-validations |
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11 |
Facility Qualification & Layouts |
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12 |
ID Request & Number Allotment Confirmation |
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13 |
IQ Protocol |
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14 |
IQ Report (Major component certification) |
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15 |
OQ Protocol |
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16 |
Calibration of Instruments |
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17 |
New SOP Number Request & Conformation |
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18 |
Operatoin, Cleaning and PM SOP's Effective & Master |
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19 |
OQ Report (Sequentional, Fumctional & Alarms) |
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20 |
Formats issuence (ACR, ECR & Log books) |
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21 |
PM and Calibration Calenders approval and Issueance |
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22 |
PQ Protocol |
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23 |
PQ Execution Data Compilation |
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24 |
Report preparation if annexures should be filling |
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25 |
Report Approval Released to Usage |
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26 |
Filing with Labling and Sent to Archival |
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