RAW MATERIAL PRE-SAMPLING INSPECTION CHECKLIST BY QUALITY CONTROL ANALYST

November 23, 2018February 2, 2023 Pharmaceutical Guidanace

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
1	Environmental Conditions	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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