SOP for Maintaining the Manufacturing Facility | Pharmaguideline
  •   Pharmaguideline Courses Start Learning
  • Apr 17, 2021

    SOP for Maintaining the Manufacturing Facility

    Standard operating procedure to maintain the facility and record the same in checklist.

    1.0 OBJECTIVE

    To lay down the procedure for maintaining and up-keeping the facility.

    2.0 SCOPE

    This SOP shall be applicable for all change rooms, production, warehouse, quality control, service floor, utility and ETP.

    3.0 RESPONSIBILITY

    Officer/ Executive

    4.0 ACCOUNTABILITY

    HOD of all Departments

    5.0 PROCEDURE

    5.1 The checklist for facility inspection.
    5.2 The checklist comprises the status of surfaces, doors, vision panels, electrical points, utility services, diffusers, light fixtures and identification tags in the room.
    5.3 There will be representatives from concerned department and engineering department for facility inspection.
    5.4 These representatives will inspect the facility as per the checklist.
    5.5 The checklists filled by the representatives shall be verified by the head of the engineering department.
    5.6 The action plan for the corrections / rectification required will be decided based on production schedule/ occupancy of the area.
    5.7 Take the prior approval from QA before starting the work.
    5.8 After completion of work representatives from concerned department and QA will inspect the area.
    5.9 If the area found satisfactory QA will clear the area for production.
    Related: Self Inspection and Quality Audits

    5.10 Frequency

    5.10.1 Once in six months.
    5.10.2 As and when requested by the user department.

    6.0 ABBREVIATION

    6.1 SOP: Standard Operating Procedure
    Get editable documentsView List

    No comments:

    Post a Comment

    Please don't spam. Comments having links would not be published.


    Popular Categories ๐Ÿท️

    QA SOPs QC SOPs Micro SOPs HVAC Production SOPs Stores SOPs Checklists Maintenance SOPs HPLC Sterile GLP Validation Protocols Water System GDP Regulatory Maintenance Calibration Warning Letters Education B.Pharmacy
    Online Courses Salary Calculator
    Follow on Whatsapp


    Certificate Courses ๐ŸŽ–️

    Pharmaceutical Courses

    Follow Pharmaguideline


    DOCUMENTS ๐Ÿ“‹

    PHARMACEUTICAL DOCUMENTS




    Editable Pharmaceutical Documents in MS-Word Format. Ready to use SOPs, Protocols, Master Plans, Manuals and more...

    View


    adsbypg


    GET APP FOR NEWS UPDATES


    Android App