SOP for Testing of Miscellaneous Samples | Pharmaguideline
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  • Apr 17, 2021

    SOP for Testing of Miscellaneous Samples

    Standard operating procedure of testing of miscellaneous samples in Quality Control.

    1.0 OBJECTIVE

    To describe the procedure for testing of the miscellaneous sample.

    2.0 SCOPE

    This SOP is applicable for the testing of the miscellaneous sample.

    3.0 RESPONSIBILITY

    Officer/ Executive - Quality Control

    4.0 ACCOUNTABILITY

    Manager – Quality Control

    5.0 PROCEDURE

    5.1 Sampling information (advice) for the sampling of any miscellaneous items has to be generated by QA department / another party.
    5.2 Sampling advice shall be forwarded to QA for sampling provided to quality assurance representative.
    5.3 Quality assurance dept. representative shall collect the sample from respective location.
    5.4 Miscellaneous sample shall be sent to quality control dept.
    5.5 Quality control dept shall record the details of the sample in the miscellaneous sample testing record as per Annexure- I.
    5.6 QC head should assign the work to chemist/supervisor and inform the results to QA head.
    5.7 Follows the test as per STP / Standard specification, and maintain the raw data in the supplementary sheet.

    6.0 ABBREVIATIONS

    6.1 SOP - Standard Operating Procedure
    6.2 No. - Number
    6.3 QA - Quality Assurance
    6.4 QC - Quality Control
    6.5 CCF - Change control format

    ANNEXURE-I
    MISCELLANEOUS /SUPPLEMENTARY RECORD
    Date
    Material / Product Name
        Batch No.
    Raw data 
    sheet No.

    Analyzed by

    Remarks

























    ANNEXURE-II 
    MISCELLANEOUS /VENDOR SAMPLE TESTING RECORD
         Date 
    Material / Product Name
       Batch No.
    A. R. No.
    Raw data sheet No.
    Tested  by
    Remarks




























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