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    Hold Time Study SOP Indian Pharma 1

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    ziaddd
    This document outlines the procedure for conducting hold time studies of intermediates. It details the responsibilities of the QA department in preparing a protocol for each study. The protocol will include the objective, scope, methodology, and evaluation criteria. All activities will be performed according to the protocol. After analysis, the QA person will document the results in a report and the manager will approve. Three consecutive batches will be studied. The protocol number will begin with JQA-HTS.

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    Hold Time Study SOP Indian Pharma 1

    Uploaded by

    ziaddd
    268 views3 pages
    This document outlines the procedure for conducting hold time studies of intermediates. It details the responsibilities of the QA department in preparing a protocol for each study. The protocol will include the objective, scope, methodology, and evaluation criteria. All activities will be performed according to the protocol. After analysis, the QA person will document the results in a report and the manager will approve. Three consecutive batches will be studied. The protocol number will begin with JQA-HTS.

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    Hold studies

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    This document outlines the procedure for conducting hold time studies of intermediates. It details the responsibilities of the QA department in preparing a protocol for each study. The protocol will include the objective, scope, methodology, and evaluation criteria. All activities will be performed according to the protocol. After analysis, the QA person will document the results in a report and the manager will approve. Three consecutive batches will be studied. The protocol number will begin with JQA-HTS.

    Copyright:

    © All Rights Reserved
    Download as DOC, PDF, TXT or read online from Scribd
    Download as doc, pdf, or txt
    268 views3 pages

    Hold Time Study SOP Indian Pharma 1

    Uploaded by

    ziaddd
    This document outlines the procedure for conducting hold time studies of intermediates. It details the responsibilities of the QA department in preparing a protocol for each study. The protocol will include the objective, scope, methodology, and evaluation criteria. All activities will be performed according to the protocol. After analysis, the QA person will document the results in a report and the manager will approve. Three consecutive batches will be studied. The protocol number will begin with JQA-HTS.

    Copyright:

    © All Rights Reserved
    Download as DOC, PDF, TXT or read online from Scribd
    Download as doc, pdf, or txt
    of 3
    At a glance
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    The key takeaways are that a hold time study protocol is prepared to determine the stability of intermediates over time and establish their acceptable hold times before further processing. The protocol outlines the objective, methodology, responsibilities, and acceptance criteria for the study.

    The purpose of conducting a hold time study for intermediates is to determine the stability of intermediates over time and establish their acceptable hold times before further processing or packaging.

    The steps involved in preparing and executing a hold time study protocol include: developing the protocol document, performing the study according to the protocol, preparing a master copy of the protocol, issuing copies to relevant departments, collecting and analyzing results, approving the final report, and conducting multiple batches of the study.

    F

    Purpose
    To conducting the hold time study of intermediates.
    2. Scope
    This procedure is applicable for hold time study of intermediates
    3. Responsibility
    Head QA & Concern department Head
    4. General conditions
    Not Applicable
    5. Precautions
    Not applicable
    6. Procedure
    6.1 Executive QA prepares the hold time study protocol having following points :
    6.1.1 A cover page having heading “Protocol for Hold Time Study for
    Intermediates”, Product name, Batch Number & Stage (i.e. Blend, core tablet,
    coating solution, coated tablets etc.)
    6.1.2 Protocol approval, containing prepared by (QA Personal), Checked by
    (Manager QC, Manager Manufacturing), & finally Approved by Manager- QA.
    6.1.3 Contents, Objective, Scope, Responsibility, Execution of Plan, Methodology,
    Establishment, Hold time study validation Procedure, Evaluation of results,
    Conclusion, Report approval & acceptance criteria, of the protocol.
    6.2 All activities are performed as per Hold Time Study protocol.
    6.3 QA personal prepares the master copy of the protocol by putting “MASTER COPY” stamp &
    sign/date on the right hand side of each page. & QA person issues the protocol with batch
    record, after photocopy of the master protocol by putting issued by stamp on the left hand
    side of the protocol on each pages. Manufacturing person receives the protocol & record is
    maintained for the same in the register.
    6.4 After analysis, QA person writes the results in the Report (attached format in the Protocol) &
    Manager QA checks the Result.
    6.5 Final report is approved by Manager QA.
    6.6 Three consecutive batches are taken for the study.
    6.7 Hold time study protocol is numbered as JQA–HTS–XXX
    Where XXX stands for 001, 002, and 003….

    7. Acceptance criteria
    As and when required
    8. Frequency
    Not Applicable

    9. Distribution
    Distribution Copy No.
    Head Quality Assurance : 01
    Display Copy (retain by QA) : 02
    Plant Head : 03
    Head Manufacturing : 04
    Head QC : 05

    JQA-001/01-00
    10. Definition/Abbreviation
    Not applicable

    11. Format for recording


    Not applicable

    12. Revision History


    Sr. No. Date of revision Revision no. Reason for revision
    (Effective Date)
    1.0 01-05-2009 00 first edition – not applicable
    2.0 01  SOP prepared on new format as SOP for SOP
    revised.
     All text revised
     Plant Head incorporated into distribution list.

    JQA-001/01-00
    JQA-001/01-00

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