- Objective:To lay down a procedure for building Maintenance.
- Scope:This Standard Operating Procedure is applicable for the formulation plant of Pharmaceutical Company.
- Responsibility:Head-Engineering /Designee shall be responsible for implementation of the procedure as per this SOP
- Accountability:Head-Concerned Department and QA shall be accountable for compliance of the procedure as per this SOP.
- Abbreviations and Definitions:
- SOP : Standard Operating Procedure
- Maintenance Work Order : A pre-printed book enclosing a form in triplicate, for the request of maintenance, comprising of three colour sheets i.e. in white and in pink colour.
- Carry out following activities as per Quarterly schedule
- Inspect the condition of the walls, floor tiles, ceiling, doors and windows of the plant building as per the Building Maintenance Checklist as per annexure-II. If cracks or damages are noticed then arrange for repairs, ensuring no product (at any stage) is lying in the area requiring repairs, preferably during holiday or complete shut down of the plant after covering of all the equipment by Concerned Departments. Ensure the proper removal of the rubble or building materials after completion of the repair.
- Inspect coving and epoxy paint of all the area. Repair the damaged coving and epoxy paint wherever required.
- Inspect all the water drainage points on the floors of the plant building and ensure that these shall not be blocked by scrap materials or not damaged. Arrange for the removal of the blocked materials.
- Check all the entry and exit doors, their hinges and stoppers and make remarks on Building Maintenance Checklist as per Annexure-II.
- Carry out repairs or modification to the building if found damaged and/or reported by Administration and Housekeeping Department / Concerned Department through Maintenance Work Order (Annexure-I).
- Inspect furniture and fixtures in the plant and office and arrange for repair or replace as required.
- Arrange for paint and white wash as and when required. It is preferable to arrange this during shut down/weekly off day of the plant in coordination with all Concerned Departments.
- Check the lighting arrester of the building and ensure that the earthings are not broken and discontinues. Arrange for repairs as needed.
- Check the utility lines for any damages and repair, if required.
- During the rainy season check for any leakages from the roof of the building or seepages of accumulated water through the wall of service floor. Mark these points and arrange for repairs and repainting works suitably.
- Record the observations on Building Maintenance Checklist. All check points as mentioned in Building Maintenance Checklist shall be checked by Engineering Personnel and status for the same shall be filled as “OK” or “NOT OK”. If it is “Not OK” then corrective action for the same shall be carried out and filled by related technician with date in ‘done on’ column and signature in ‘done by’ column. After completion of work, the checklist shall be verified by Head-Engineering.
- Engineering person shall prepare the deparment wise building Maintenance check list as per the Annexure -2 and submit the list to QA Department
- QA person shall review the list and make it master by stamping “MASTER COPY” it and prepare controlled copy of the master copy for distribution to separate departments
- QA person shall issue the controlled copy of the building Maintenance Check list to different department as per the requirement.
- Forms and Records
- Maintenance Work Order : Annexure-I
- Building Maintenance Checklist : Annexure-II
- Master Copy: Documentation Cell
- Controlled Copies :Engineering, Quality Assurance, Production, Quality Control, Warehouse, Administration and Housekeeping
Reason for Revision
Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field.
During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube