Biomedical Engineering Reference
In-Depth Information
LEVEL 4
Attachment III
SOP No.:
Issued on:
Revision No.:
Initiator name:
CHECKLIST FOR BATCH DOCUMENTS
ALONG WITH SAMPLES (BULK PRODUCT)
Product:
Mfg.:
Code No.:
Expiry:
Batch No.:
Stage:
Bulk
Weighing Area Records
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1. Batch manufacturing record
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2. Raw materials weighing record with print out
▭
3. Weighing area clearance check list with cleaning status label
Production Area Documents
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1. Batch manufacturing record
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• Master formula
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• Bill of materials
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2. Sanitization record of the area (suspension)
Packaging Area Documents
Batch packaging record
QA In-Process
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1. Sampling report (manufacturing side)
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2. QA in-process records
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a.
Weight variation format (tablets, capsules, suppositories, parenterals)
▭
b.
Inspection start-up checklist with release label
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c.
Visual inspection for parenterals
▭
d.
Weighing area checklist signed by QAI
Any Other Documents
▭
1. Process change request
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2. Memo (sorting or any other)
▭
3. Waiver document
▭
4.
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