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

Image result for quality control analyst

 

Thank you for visit and for more pharma updates click here – https://pharmaguidances.com

 

About Pharmaceutical Guidanace

Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

Check Also

Equipment in Pharma company as per USFDA

Equipment in Pharma company as per USFDA Equipment design, size, and location (§ 211.63) in …