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
1. Batch manufacturing record
2. Raw materials weighing record with print out
3. Weighing area clearance check list with cleaning status label
Production Area Documents
1. Batch manufacturing record
• Master formula
• Bill of materials
2. Sanitization record of the area (suspension)
Packaging Area Documents
Batch packaging record
QA In-Process
1. Sampling report (manufacturing side)
2. QA in-process records
a.
Weight variation format (tablets, capsules, suppositories, parenterals)
b.
Inspection start-up checklist with release label
c.
Visual inspection for parenterals
d.
Weighing area checklist signed by QAI
Any Other Documents
1. Process change request
2. Memo (sorting or any other)
3. Waiver document
4.
 
Search WWH ::




Custom Search