SOP for Maintaining the Manufacturing Facility : Pharmaceutical Guidelines

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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
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Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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