To lay down a standard procedure for receiving, distribution, testing and reporting of all In-Process Finish Product Samples.
This procedure is applicable for samples receiving, distribution, testing and reporting of all In-Process Finish Product Samples in Quality Control Laboratory at
Officers / Executive – Quality Control.
4.1 Manager- Quality Control and Head QA shall be accountable for compliance of this SOP.
Format for in-Process Finished Sample Inward Register Attachment-I
- Officer Quality Control shall receive the Intimation slip along with sample from Quality Assurance Department.
- Officer Quality Control shall make entry in the In-Process Finish Product Sample inward register and allocate the Analytical report number as per Format- SOP/QC/005/F01-00.
- Officer Quality Control shall make entry generate ID No. according to inward register.
- After login in inward register the sample forward to Executive-Quality Control for distribution.
- Executive Quality Control shall distribute the sample to analyst for analysis on the basis of priority,
- After distribution of work, analyst shall analyze the samples as per approved specifications and Standard Testing Procedure and record the details in respective analytical record.
- Procedure for analysis shall be same for all instrumental analysis (i.e. first run / inject a blank solution then run / inject three replicate of standard solution after that run / inject two sample solutions,)
- System suitability shall be checked as per individual monograph or calculate the % RSD for replicate standard solution, % RSD should not be more than 2% for replicate run / injection.
- Response / Area of standard sample run / inject after test sample should not be more than ± 2% of average of three replicate of standard solution.
- Calculation shall be done by using average response / area of standard and sample solution.
- Attach all the chromatogram, raw data, weighing record, readings & other supportive document with obtained analytical record.
- After completion of testing, the analyst must complete and sign the analytical record and all the supportive documents.
- After completion of analysis, analyst will hand over the analytical record and other documents to Executive Quality Control for reviewing.
- After reviewing, Executive Quality Control shall generate COA as per format.
- The COA shall be checked and signed by the analyst after comparing it with the analytical record.
- Executive-Quality Control shall review the Certificate of Analysis, forward to Head Quality Control for final approval.
- After reviewing and signing of COA, Manager Quality Control will approve the same.
- Approved COA shall be forwarded to Quality Assurance Department.
- Quality Assurance personal shall release the material.
Note: In case of any discrepancy during analysis analyst shall inform to Manager Quality Control.
SOP: Standard Operating Procedure
QC: Quality Control.
COA: Certificate of Analysis
RSD: Relative Standard Deviation
QA: Quality Assurance
- DISTRIBUTION LIST
Quality Assurance Department
Quality Control Department
- HISTORY OF REVISION
|Version No.||Date of Revision||Reason for Revision|