SOP FOR STARTUP PROCEDURE AFTER SHUT DOWN
1.0 OBJECTIVE
To lay down the procedure for startup production area after shut down.
2.0 Scope
This SOP is applicable for aseptic filling area which was under shutdown at Pharmaceuticals manufacturing.
3.0 RESPONSIBILITY
QA manager
Production Manager
4.0 ACCOUNTABILITY
General Manager
5.0 PROCEDURE
5.1 Definitions
5.1.1 Major Shut Down: The activities which have a major impact on the quality of the product such as:
5.1.1.1 Civil works in the area.
5.1.1.2 Major Maintenance activity.
5.1.1.3 HVAC shutdown / Power failure for more than 12 hours.
5.1.2 Minor Shut Down: The activities which have a low impact on the quality of the product such as
5.1.2.1 HVAC shutdown for less than 12 hours.
5.1.2.2 Preventive maintenance activity.
5.1.2.3 Minor modifications in the area.
5.1.2.4 Power failure for less than 12 hours.
5.1.3 Interruptions: The activities which has very low or no impact on the quality of the product such as
5.1.3.1 HVAC shutdown for less than 30 minutes.
5.1.3.2 Minor maintenance activity.
5.1.3.3 Power failure for less than 30 minutes.
5.1.3.4 Validation activity.
5.2 Procedure
5.2.1 Procedure for restart after major shut down
5.2.1.1 For restart after major shut down, consecutively three days fogging with 2% virosil for minimum six hours to be done.
5.2.1.2 Ask Engineering personnel to Start Air Handling units.
5.2.1.3 Allow the area to be de fogged for at least 1 hour.
5.2.1.4 Re-clean and sanitize the area as per SOP ensuring that the floors, walls and ceiling are cleaned and sanitized.
5.2.1.5 Clean all the equipments present inside aseptic area thoroughly externally and internally as per their respective SOP’s
5.2.1.6 Perform environmental monitoring as per SOP
5.2.1.7 Perform Non viable particle counts in the aseptic area. Particle counting should be carried out in all aseptic area.
5.2.1.8 Testing operations should be performed only after achieving the environmental conditions suitable for non-viable and viable particle counts.
5.2.1.9 The final approval to start the area should be given by Quality Assurance after reviewing all the data and ensuring compliance to the requirements.
5.2.2 Procedure for restart after minor Shut Down
5.2.2.1 Before taking the lab under operation after minor shut down following operations should be carried out.
5.2.2.2 Ensure that the Air Handling units are in operation.
5.2.2.3 Allow the area to stabilize for at least 1 hr.
5.2.2.4 Clean and sanitizes the area as per SOP ensuring that all the floors, walls and ceiling are cleaned and sanitized.
5.2.2.5 Clean all the equipments present in aseptic area thoroughly externally and internally as per their respective SOP’s
5.2.2.6 Perform microbial environmental monitoring as per SOP
5.2.2.7 Perform Non viable particle counts in the area. Particle counting should be carried out in all rooms.
5.2.2.8 Filling operations should be performed after achieving the environmental conditions suitable for non-viable particle counts.
5.2.2.9 The final approval to start the area should be given by Quality Assurance after reviewing all the data and ensuring compliance to the requirements.
5.2.3 Procedure for restart after Interruptions.
5.2.3.1 Before restarting filling activity after interruptions, following activity should be carried out.
5.2.3.2 Ensure that the Air Handling units are in operation.
5.2.3.3 Clean and sanitizes the area as per SOP ensuring that the floors and walls are cleaned and sanitized.
5.2.3.4 Perform microbial environmental monitoring as per SOP
5.2.3.5 filling operations can be initiated after Quality Assurance checks for proper cleaning.
6.0 ABBREVIATIONS
6.1 SOP – Standard Operating Procedure
6.2 HVAC – Heating Ventilating Air Conditioning
7.0 REFERENCES
In-house.
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B. Pharma Notes | B. Pharma Notes | Study material Bachelor of Pharmacy pdf