SOP FOR SAMPLING ANALYSIS AND APPROVAL/ REJECTION OF RAW MATERIAL

SOP FOR SAMPLING ANALYSIS AND APPROVAL/ REJECTION OF RAW MATERIAL

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1.0 OBJECTIVE

To lay down a standard procedure for receiving, distribution, testing and reporting of all raw materials.

2.0 SCOPE

This procedure is applicable for receiving, distribution, testing and reporting of all raw materials in     Quality Control Laboratory at Sano Cito therpapeutics Inc. Unit-2 Vill. Loharan P.O. Ghatti Solan- 173211 (H.P.)

3.0 RESPONSIBILITY

    • Officers / Executive – Quality Control.

4.0    ACCOUNTABILITY                                                                                                                             

  • Manager- Quality Control and Head QA shall be accountable for compliance of the SOP.

5.0 ATTACHMENTS

   Format for raw Material inward register                                Attachment-I

6.0 PROCEDURE

  •  Officer Quality Control shall receive the Raw Material Intimation slip along with Supplier’s Certificate of Analysis from Raw Material Store.
  • Officer Quality Control shall make entry in the Raw material inward register and allocate the AR No.  as per Attachment-I.
  • Officer Quality Control shall make entry generate AR No. according to inward register.
  • Officer Quality Control / designated for sampling shall draw the Raw material sample and attach the sample label on the sampled container as attachment-II.
  • Drawn sample shall be handed over to Executive Quality Control for Distribution.
  • Executive Quality Control shall distribute the sample to analyst for analysis on the basis of priority in consultation with warehouse and production departments.
  • Executive Quality Control above shall hand over the sample to analyst.
  • 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 as per format. Procedure for analysis shall be same for all instrumental analysis.
  • 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.
  • Calculation shall be done by using average response / area of standard and sample solution.
  • Attach all the chromatogram, raw data, weights, readings & other supportive document with 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 in computer system.
  • 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, Head Quality Control will approve the same.
  • A copy of approved COA shall be forwarded to Raw material Store.
  • Executive Quality Control shall release the material.
  • In case of any discrepancy during analysis analyst shall inform to Executive Quality Control.
  • REFERENCES

In-house

  • ABBREVIATIONS

SOP: Standard Operating Procedure

QC: Quality Control.

COA: Certificate of Analysis

GRN: Goods Receipt Note

FT: Format.

QA: Quality Assurance

RSD: Relative Standard Deviation

9.0      DISTRIBUTION LIST

Quality Assurance Department

Quality Control Department

Warehouse

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

 

SOPs