SOP for receiving, distribution, testing & reporting of in-process finish product samples

SOP for receiving, distribution, testing & reporting of in-process finish product samples

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1.0 OBJECTIVE

To lay down a standard procedure for receiving, distribution, testing and reporting of all In-Process Finish Product Samples.

2.0    SCOPE

This procedure is applicable for samples receiving, distribution, testing and reporting of all In-Process Finish Product Samples in Quality               Control Laboratory at

3.0 RESPONSIBILITY

Officers / Executive – Quality Control.

4.0 ACCOUNTABILITY

4.1    Manager- Quality Control and Head QA shall be accountable for compliance of this SOP.

5.0  ATTACHMENTS

Format for in-Process Finished Sample Inward Register                      Attachment-I

6.0   PROCEDURE

  •  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.

  • REFERENCES

In-house

  • ABBREVIATIONS

SOP: Standard Operating Procedure

QC: Quality Control.

COA: Certificate of Analysis

RSD: Relative Standard Deviation

F: Format

QA: Quality Assurance

  • DISTRIBUTION LIST

Quality Assurance Department

Quality Control Department

  1. HISTORY OF REVISION
Version No. Date of Revision Reason for Revision

 

 

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