SOP for Procedure of shutdown and startup of Facility
Objective
To lay down the procedure of shutdown and start-up after shutdown of Facility.
Scope
This SOP is applicable for procedure of shutdown and start up after shutdown of Facility in the formulation plant.
Responsibility
All personnel working in respective areas.
Accountability
Head of all respective departments and Head – QA for compliance of this SOP.
Smoke Study in Clean Rooms of Pharmaceuticals
Procedure
Type of Shutdown:
Major Shutdown: The activities which have a major impact on the quality of product and processing area involved in the facility such as:
- Civil works in the area.
- Major Maintenance activity.
- HVAC shutdown / Power failure for more than 12 hours.
- Major Shutdown is always planned shutdown.
Minor Shutdown: The activities which have a minor impact on the quality of product and processing area involved in the facility such as:
- HVAC shut down for one to 12 hours.
- Preventive maintenance activity.
- Minor modifications in the area.
- Power failure for one to 12 hours.
- Minor Shutdown is always planned shutdown.
Shutdown Due to Power Failure: The activities which have very low or no impact on the quality of product and processing area involved in the facility such as:
- HVAC shut down for less than 30 minutes.
- Minor maintenance activity.
- Power failure for more than 30 minutes to one hour.
- Shutdown due to power failure may be planned/ unplanned shutdown.
Procedure:
Procedure of shutdown
- Before Major/Minor Shutdown of the area; following activities to be performed:
- QA will inform all respective departments through written communication about the shutdown of facility, type of shutdown, time period of shutdown, reason for shutdown and scope of shutdown.
- QA will provide the shutdown plan and propose the activities to be performed during shutdown, as follows:
- All production / process related activities should be completed before shutdown.
- Switch OFF the power mains of equipment by isolation of connection.
- Check and ensure the product material containers are in closed /covered condition, with appropriate identification.
- Close all processing equipment with their respective closures.
Procedure for restart after major shutdown
- For restart after major shutdown thorough cleaning/sanitization of floor, walls, ceiling, doors and window panels will be done, as per respective SOPs.
- Instruct Engineering personnel to start Air Handling Units.
- Allow the flow of fresh filtered air into the process areas for at least 2 hours.
- Again clean and sanitize the area as per SOP ensuring that the floor, walls and ceiling are cleaned and sanitized.
- Thoroughly clean all equipment present in the facility, externally and internally, as per their respective SOPs.
- Perform microbial environmental monitoring as per respective SOP.
- Perform the various tests for area qualification if required to ensure the area validation.
- Operations should be performed only after achieving the environmental conditions as per respective area requirement.
- If any change/modification has been done in equipment, area or facility, well-established risk analysis and impact analysis shall be performed with proper justification and scientific rationale.
- The final approval to start the area should be given by Quality Assurance only after reviewing all the data and ensuring compliance to the requirements.
Procedure for restart after minor shutdown :
- Before taking the facility under operation after minor shutdown following operations should be carried out:
- Ensure that the Air Handling Units are in operation.
- Allow the flow of fresh filtered air into the process areas for at least 2 hours.
- Clean and sanitize the area as per SOP ensuring that all the floor, walls and ceiling are cleaned and sanitized.
- Thoroughly clean all equipment present in the facility, externally and internally, as per their respective SOPs.
- Perform microbial environmental monitoring as per respective SOP.
- Perform the various tests for area qualification if required to ensure the area validation.
- Operations should be performed only after achieving the environmental conditions as per respective area requirement.
- If any change/modification has been done in equipment, area or facility, well-established risk analysis and Impact analysis shall be performed with proper justification and scientific rationale.
- The final approval to start the area should be given by Quality Assurance only after reviewing all the data and ensuring compliance to the requirements.
Procedure for restart after Shutdown due to power failure.
- Before taking the area under operation after shutdown due to power failure, follow the respective SOP of Preventive measures to be taken during power failure.
List of Annexure / Format
| Sr. No. | Title | Annexure No. |
| 1 | Pre- requisition for shutdown of facility/ area | |
| 2 | Startup post-shutdown of facility/ area |
References
None
Revision History
Not Applicable
Abbreviations
SOP: Standard Operating Procedure
ETP: Effluent Treatment Plant
HVAC: Heating. Ventilation and Air Conditioning
SCALE-UP AND POSTAPPROVAL CHANGES (SUPAC) GUIDANCE FOR INDUSTRY: A REGULATORY NOTE
