Home / Audit and Guideline / RAW MATERIAL PRE-SAMPLING INSPECTION CHECKLIST BY QUALITY CONTROL ANALYST

RAW MATERIAL PRE-SAMPLING INSPECTION CHECKLIST BY QUALITY CONTROL ANALYST

RAW MATERIAL PRE-SAMPLING INSPECTION CHECKLIST BY QUALITY CONTROL ANALYST

Material Name:

AR No./MRR No./ Date:

SNo. Description Check Point
1 Environmental Conditions Temperature
RH
2 Under test label Affixed / Not affixed
3 Packing Packed in carboys / drums
Packed in fiber/plastic drums with polybag inside
Packed in PP woven bags with polybag inside
Packed in polybag with corrugated box
Packed in Polybag and paper bag
4 Packing condition Satisfactory/Not Satisfactory

(If not satisfactory write observations)

5 Check the container labels for the presence of following details and record
Pharmacopoeial status IP/BP/ USP/NF/EP
Manufacturers name Mentioned/Not Mentioned
Batch No. Mentioned/Not Mentioned
Date of manufacturing Mentioned/Not Mentioned
Date of expiry Mentioned/Not Mentioned
Quantity Mentioned/Not Mentioned
Container number if any Mentioned/Not Mentioned
Storage conditions Mentioned/Not Mentioned
Any other remarks, specify Mentioned/Not Mentioned
6 Physical appearance Conforms /Not Conforms
Presence of lumps Present/ Absent
Any non-characteristic odour Present/ Absent
Heterogeneity with in same container Present/ Absent
Heterogeneity between container to container Present/ Absent
Any other abnormality Present/ Absent
7 Original Manufacturer’s seal (if imported) available Yes/No
8 Supplier test certificate Received/Not Received
9 Any Remarks  

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