1.0 OBJECTIVE:To lay down the procedure for the intimation of breakdown of utilities services & equipments in manufacturing & packing department during working.
2.0 SCOPE:This SOP shall be applicable for the intimation of breakdown of all the utilities services & equipments in the manufacturing & packing department.
3.0 RESPONSIBILITY:3.1 Execution : Operator
3.2 Checking : Production Pharmacist & Above
4.0 ACCOUNTABILITY:HOD-Production / Assigned Designee
5.0 PROCEDURE:5.1 The breakdown of utilities services includes:-
5.1.1 If air pressure is not up to requirement to starts activity.
5.1.2 Inform to maintenance department by Telephonic & followed with intimation.
5.1.3 Before starting equipment after breakdown we are going to clean it as per SCP & take trial before loading the product about the proper functioning & unusual sound.
5.1.4 If there power failure, we have been provided to backup system arrangement of UPS for lighting & diesel generator set for power supply & start the equipment after communication by maintenance department.
5.1.5 If there is water supply problem, we have been provided to backup pump system arrangement by maintenance department.
5.2 In case of stoppage of utilities supplies & equipment following procedure to be followed:-
5.2.1 Inform to maintenance department by oral / telephonic & followed with intimation.
5.3 If the supply does not start after 10 minutes follow the following procedure:-
5.3.1 In case of steam failure during drying, continue the drying at ambient temperature.
5.3.2 In case of electrical failure during coating, unload the tablet from the pan after 30 minutes.
5.3.3 In case of compressed air failure during coating. Remove spray gun assembly from the pan. Dry the tablet & unload the tablet from the pan.
5.3.4 In case of electricity / utility failure during compression remove the granules from the hopper into container.
5.4 In case of equipment break down inform to maintenance department orally & followed with maintenance intimation note.
5.5 In case of electricity failure during strip / blister packing remove the tablet from the feeding Channel and hopper. Discard & destroy the tablet which is under sealing roller. After receiving the electricity supply, check the leak test & printing matter before starting as per SOP & BPR.
5.6 Fill the incident report & Start the activity after taking the job done intimation copy & approval of Q.A. Person. Attach the incident report copy into BMR.
6.0 ABBREVIATIONS:6.1 SOP: Standard Operating Procedure
6.2 BMR: Batch Manufacturing Record
6.3 Q.A.: Quality Assurance
6.4 HOD: Head of The Department
6.5 BPR: Batch Packing Record
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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