Scribd Logo
Upload

Welcome to Scribd!

  • 953 views

    Capa Form

    Uploaded by

    Zahid Nazir
    This CAPA form documents the investigation into the presence of hair in filled vials of Cefotrim Injection. The root cause was determined to be deficiencies in aseptic practices and environmental controls in the cephalosporin dry powder injectable area. Corrective actions included providing laminar flow cabinets for storage and feeding of materials, training staff on aseptic techniques, and implementing in-process clarity testing and 100% visual inspection of filled vials. Preventive actions focused on training and refresher courses for staff working in aseptic areas.

    Copyright:

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

    Capa Form

    Uploaded by

    Zahid Nazir
    953 views3 pages
    This CAPA form documents the investigation into the presence of hair in filled vials of Cefotrim Injection. The root cause was determined to be deficiencies in aseptic practices and environmental controls in the cephalosporin dry powder injectable area. Corrective actions included providing laminar flow cabinets for storage and feeding of materials, training staff on aseptic techniques, and implementing in-process clarity testing and 100% visual inspection of filled vials. Preventive actions focused on training and refresher courses for staff working in aseptic areas.

    Original Description:

    CAPA Form

    Original Title

    CAPA FORM

    Copyright

    © © All Rights Reserved

    Available Formats

    DOCX, PDF, TXT or read online from Scribd

    Did you find this document useful?

    Is this content inappropriate?

    This CAPA form documents the investigation into the presence of hair in filled vials of Cefotrim Injection. The root cause was determined to be deficiencies in aseptic practices and environmental controls in the cephalosporin dry powder injectable area. Corrective actions included providing laminar flow cabinets for storage and feeding of materials, training staff on aseptic techniques, and implementing in-process clarity testing and 100% visual inspection of filled vials. Preventive actions focused on training and refresher courses for staff working in aseptic areas.

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    953 views3 pages

    Capa Form

    Uploaded by

    Zahid Nazir
    This CAPA form documents the investigation into the presence of hair in filled vials of Cefotrim Injection. The root cause was determined to be deficiencies in aseptic practices and environmental controls in the cephalosporin dry powder injectable area. Corrective actions included providing laminar flow cabinets for storage and feeding of materials, training staff on aseptic techniques, and implementing in-process clarity testing and 100% visual inspection of filled vials. Preventive actions focused on training and refresher courses for staff working in aseptic areas.

    Copyright:

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

    CAPA FORM

    CAPA Ref. No.

    Start Date:

    CAPA
    SOURCE

    Non-Conformity
    from Audits

    CATEGORY

    Document
    Control

    From
    Complaints /
    Notices/ Third
    Parties

    System Failure

    Suggestion for
    Improvement

    Others
    ---------------------------

    Training/Operator
    Fault

    Wrong Procedure
    /Instructions

    Non-Conformity / Complaint / Observation


    Presence of hair in filled and reconstituted vials of Cefotrim Injection 1gm Batch No. 281.

    Current Status
    Not Applicable

    CAPA Leader & Team


    CAPA Leader:

    Zahid Nazir

    Team Members:

    1.

    Abdul Karim
    4.

    2.

    M. Nasir

    3.

    5.

    6.
    Root Cause Analysis
    Tool Used:
    Fishbone Analysis, Cause and Effect Diagram, Gemba, Brain Storming,
    Conclusion:
    Following are deficiencies in Ceph. Dry Powder Injectable area which can be the potential cause
    of contamination in
    Filled vials.
    i). After Sterilization, depyrogenated vials are stored in SS Trays without Lid.
    ii). Vials are fed to the turntable manually without Laminar Flow Protection.
    iii). Rubber Stoppers are stored in a SS container in Class B area (open to environment) and fed
    into the stopper hopper
    with a SS bowl without Laminar Flow Protection.

    Page 1 of 3
    CAPA Form
    Ref SOP No. QA/GEN/005/01

    iv). Powder is fed into the Powder Hopper by opening the filling cabinet door.
    v). Ways of Working of Staff is not as per standard aseptic practices.
    vi). There is no in-process testing for Clarity.
    vii). There is no visual inspection of filled vials under illuminated background.

    CAPA Leader:
    ______________________
    ____________________________

    QA Manager:

    Corrective & Preventive Action (CAPA)


    Corrective Action

    Responsibilit
    y

    Target
    Completion
    Date

    Actual
    Completion
    Date

    Responsibilit
    y

    Target
    Completion
    Date

    Actual
    Completion
    Date

    Provision of Storage LFC in cooling area for


    the storage of depyrogenated vials, seals,
    rubber stoppers etc.
    Use of SS trays with lid for depyrogenated
    vials and modification in LFC for feeding of
    vials.
    Storage of Rubber Stoppers under LAF.
    Training of staff working in Sterile area on
    aseptic techniques.
    Inclusion of Clarity Test as in-process check
    after every 30 minutes of filling.
    100% visual inspection of filled vials before
    labeling operation.
    Preventive Action
    Training and refresher courses for
    management and non-management staff
    working in aseptic areas.

    CAPA Approved By
    QA Manager : ______________________________
    ___________________________

    Head of Plant Operations:

    Page 2 of 3
    CAPA Form
    Ref SOP No. QA/GEN/005/01

    Post Implementation Review

    CAPA Leader:
    ______________________
    ____________________________

    QA Manager:

    CAPA Closure

    CAPA Leader:
    ______________________
    ____________________________

    QA Manager:

    Page 3 of 3
    CAPA Form
    Ref SOP No. QA/GEN/005/01

    You might also like