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  • Medioint Lifescience PVT - LTD.: Standard Operating Procedure

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    Choudhary Dhiraj
    72 views3 pages
    This document outlines standard operating procedures for the receipt, storage, usage, and integrity record of sieves at Medioint Life science Pvt. Ltd. It describes procedures for checking sieves upon receipt and before and after batch manufacturing. Sieves must be intact with no deformation and equal distances between wires. Records of sieve inventory and integrity checks are maintained for compliance.

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    PRD 020

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    This document outlines standard operating procedures for the receipt, storage, usage, and integrity record of sieves at Medioint Life science Pvt. Ltd. It describes procedures for checking sieves upon receipt and before and after batch manufacturing. Sieves must be intact with no deformation and equal distances between wires. Records of sieve inventory and integrity checks are maintained for compliance.

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    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
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    72 views3 pages

    Medioint Lifescience PVT - LTD.: Standard Operating Procedure

    Uploaded by

    Choudhary Dhiraj
    This document outlines standard operating procedures for the receipt, storage, usage, and integrity record of sieves at Medioint Life science Pvt. Ltd. It describes procedures for checking sieves upon receipt and before and after batch manufacturing. Sieves must be intact with no deformation and equal distances between wires. Records of sieve inventory and integrity checks are maintained for compliance.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
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    of 3

    MEDIOINT LIFESCIENCE PVT.LTD.

    Plot No.260 A, Sector-III Pithampur, Dist. Dhar-454774(M.P)


    PRODUCTION DEPARTMENT
    STANDARD OPERATING PROCEDURE
    SOP No. PRD 020 Effective Date
    Revision No. 00 Review Date
    Supersedes Nil Page No. 1 of 3
    SOP FOR RECEIPT, STORAGE, USAGE,
    TITLE
    AND INTEGRITY RECORD OF SIEVES.

    1.0 PURPOSE:
    To lay down the procedure for receipt, storage, usage, and integrity record of sieves.
    2.0 SCOPE:
    This SOP is applicable to provide the written guidelines for receipt, storage, usage, and
    integrity record of sieves in production at Medioint Life science Pvt. Ltd., Pithampur.
    3.0 RESPONSIBILITY:
    3.1 Production Operator/Production Officer/Executive and above shall be responsible for receipt,
    storage, usage, and integrity of sieves.
    3.2 Quality Assurance Officer/Executive and above shall be responsible for verify the integrity
    record of sieves
    3.3 Accountability:
    Head of Production Department to ensure implementation of this SOP.
    Head of Quality Assurance Department to ensure compliance of procedure.
    4.0 SAFETY AND PRECAUTION:
    5.0 ABBREVIATION:
    SOP - Standard Operating Procedure
    PRD - Production Department
    END - Engineering Department
    F - Format
    Pvt. Ltd. - Private Limited
    M.P. - Madhya Pradesh
    SLS - sodium lauryl sulfate
    6.0 DEFINITION:
    Not Applicable

    Prepared By Reviewed By Approved By Authorized By


    Signature
    Date
    Name
    Designation Production Production Production QA Manager
    Officer Executive Manager
    MEDIOINT LIFESCIENCE PVT.LTD.
    Plot No.260 A, Sector-III Pithampur, Dist. Dhar-454774(M.P)
    PRODUCTION DEPARTMENT
    STANDARD OPERATING PROCEDURE
    SOP No. PRD 020 Effective Date
    Revision No. 00 Review Date
    Supersedes Nil Page No. 2 of 3
    SOP FOR RECEIPT, STORAGE, USAGE,
    TITLE
    AND INTEGRITY RECORD OF SIEVES.

    7.0 PROCEDURE
    7.1 RECEIPT
    7.1.1 On intimation of receipt from stores, collect all the sieves
    7.1.2 Check the integrity of individual sieves as per step no. 7.3
    7.1.3 Remark ‘OK’ for pass sieves and ‘Not OK’ for sieves which fail the integrity test. Return backs
    the defective sieves to stores.
    7.1.4 Allot code no. as per Coding SOP to the pass sieves and transfer the respective storage area.
    7.1.5 Record the observations in PRD 020/F01.
    7.2 Storage
    7.2.1 After completion of activity clean and place sieve/screen in virgin polybag, label, and store
    dedicated almira.
    7.3 INTEGRITY SIEVES
    7.3.1 Integrity of sieve shall be checked on the following occasion
    a) Newly received sieve.
    b) Before starting the manufacturing activity for any batch.
    c) After completion of the batch.
    7.3.2 Newly received sieve.
    7.3.2.1 Remove the sieve from polybag
    7.3.2.2 Hold the sieve and keep it against the tube light
    7.3.2.3 Rotate clockwise and anticlockwise direction and check visually against light
    7.3.2.4 Ensure that the sieve wires are in equal distance when compared to another.
    7.3.2.5 Check for the intactness / damage of wire in sieve or screen.
    7.3.3 Before starting the manufacturing activity for any batch and After completion of the batch.
    7.3.3.1 Hold the sieve and keep it against the tube light

    Prepared By Reviewed By Approved By Authorized By


    Signature
    Date
    Name
    Designation Production Production Production QA Manager
    Officer Executive Manager
    MEDIOINT LIFESCIENCE PVT.LTD.
    Plot No.260 A, Sector-III Pithampur, Dist. Dhar-454774(M.P)
    PRODUCTION DEPARTMENT
    STANDARD OPERATING PROCEDURE
    SOP No. PRD 020 Effective Date
    Revision No. 00 Review Date
    Supersedes Nil Page No. 3 of 3
    SOP FOR RECEIPT, STORAGE, USAGE,
    TITLE
    AND INTEGRITY RECORD OF SIEVES.

    7.3.3.2 Rotate clockwise and anticlockwise direction and check visually against light
    7.3.3.3 Ensure that the sieve wires are in equal distance when compared to another.
    7.3.3.4 Check for the intactness / damage of wire in sieve or screen.
    7.3.3.5 Integrity of sieve shall be counterchecked by IPQA person.
    7.3.3.6 After checking by IPQA person wrap the sieve in polybag after cleaning and drying of the
    sieve.
    7.3.3.7 In case of integrity failure, reject and destroy the sieve and replace with new one.
    7.3.3.8 Record the status of the sieves to be used for the product and after use of the product in the
    PRD 020/F02.
    7.5 Acceptance Criteria: Sieve should be in intact position and no deformation in distance.
    8.0 FREQUENCY:
    8.1 Before starting of the batch and After Completion of the Batch. Record the status of the sieves
    to be used for the product and after use of the product in the PRD 020/F02.
    9.0 SUPPORTING DOCUMENTS:
    Format No. PRD 020/F01 : Sieves inventory record
    Format No. PRD 020/F02 : Integrity checking record of sieves
    Format No. QAD 002/F11 : Format for History Sheet.
    10.0 REFERENCE:
    In House.

    Prepared By Reviewed By Approved By Authorized By


    Signature
    Date
    Name
    Designation Production Production Production QA Manager
    Officer Executive Manager

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