Resampling & Retesting of Materials

  1. Objective

To lay down procedure for resampling & retesting of materials.

  • Scope

        This SOP is applicable in quality control for resampling & retesting of materials.                                         

  • Responsibility

QC Chemist / Officer     : To follow the procedure and maintain as applicable.          

  • Accountability

Head Quality Control     : For system Compliance

  • Procedure:  
    • After reporting of Out of specification results QC Chemist should inform to Head QC/ designee.
    • OOS shall be logged and investigate and record all the observations carefully.
    • If required retesting & resampling of materials shall be done as per the procedure.
    • Retesting: If there is no laboratory error then retesting of material shall be done following the instruction in “Out of Specification”.
    • Resampling :
      • Resampling shall be done in only if there are reasons to believe that the original sample was not representative.
      • Do not resample except when there are reasons to suspect non representative nature of the sample.
    • All the observation shall be submitted for review.
    • Make the final report.
  • Annexure (S)

            -NA-

  • Reference (S)

             SOP for out of specification

  • Glossary           

SOP                    :  Standard Operating Procedure

HOD                    :  Head of Department

QC                      :  Quality Control

QA                       :  Quality Assurance

OOS                   :  Out of Specification

  • Revision History
Rev. No. Details of changes Reason for change

Bhanu Pratap Singh

BHANU PRATAP SINGH IS EXPERIENCED IN PHARMACEUTICAL, AUTHOR AND FOUNDER OF PHARMACEUTICAL GUIDESLINE (WWW.PHARMAGUIDESLINE.COM), A WIDELY READ PHARMACEUTICAL BLOG SINCE 2019. EMAIL:- INFO@PHARMAGUIDESLINE.COM

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