Sterile Manufacturing Batch Record
1. Pre-Manufacturing Checks
| Description |
Checked By |
Date / Time |
Remarks |
| Line Clearance |
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| Equipment Cleaning / Status |
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| Environmental Condition |
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| Material Availability |
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2. Material Details
| Material Name |
Lot / Batch No. |
Quantity Issued |
Checked By |
Date |
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3. Manufacturing Process
| Step / Operation |
Performed By |
Date / Time |
Remarks |
| Dispensing |
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| Preparation / Mixing |
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| Filtration |
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| Filling |
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| Sealing |
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| Inspection |
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| Labeling & Packaging |
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4. In-Process Controls
| Parameter |
Specification |
Result |
Checked By |
Date / Time |
| pH |
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| Osmolality |
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| Volume |
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| Appearance |
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5. Yield Calculation
| Theoretical Yield |
Actual Yield |
Yield % |
Checked By |
Date / Time |
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6. Comments / Deviations / Incidents
| Description |
Reported By |
Date / Time |
Action Taken |
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7. Verification and Release
Manufacturing In-Charge:
Date: