LINE CLEARANCE CHECKLIST OF AREA & EQUIPMENT FOR PRIMARY PACKING
| Dosage Form: |
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Date / Time: |
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| Product: |
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Batch No. : |
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| Previous product: |
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Batch No. : |
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| Stage areas / Equipment Name |
Checks |
Checked by
Production
Date & Time |
Counter checked By Quality Assurance
Date & Time |
| PACKING [Released / Not Released / Hold / Rejected / Not Applicable] |
| Packing Room |
Room ID No.: ____________________
- Ensure the absence of batch documents, labels, materials, powder, tablets, or remnants of previous product or batch.
- Ensure ‘CLEANED’ label is affixed on each equipment.
- Ensure updation of Status Board
- Temperature [24 ± 2°c]
- Relative Humidity [35 – 50 %]
- Differential Pressure [10 – 26 Pascal]
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CLEANLINESS OF
- Floor
- Walls
- Ceiling
- Drain
- Container
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- Light Fixtures
- Tools
- Waste Bins
- Supply air Grills
- Return air Grills
- Area under packing Machine
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| Blister Packing Machine / Strip packing machine / Defoiling Machine |
Equipment ID No.: ________________
- Ensure the absence of materials / Powder / tablets / Aluminum foil / PVC foil / PVDC foil / Printed foil / Strips / Blisters or remnants of previous product or batch & traces of water.
- Pass box cleanliness.
- Overprinting Stereos of previous batch or product are destroyed.
- Area surrounding the Equipment
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