Pharmaceutical Guidance Complete Pharma Solution
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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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
