cGMP and Regulatory Updates

1.0 SCOPE: Applicable to BOPP tape dispenser manufactured by ITW Signode India Limited. 2.0 RESPONSIBILITY: Operator, Production Officer. 3.0 PROCEDURE: 3.1 Ensure that the machine labeled as ‘TO BE CLEANED’ (LBPR:xxxx). 3.2 Switch ‘OFF’ the main power supply to the machine. 3.3 Remove both the BOPP tape rolls. 3.4 Clean the cutting blades with wet lint free cloth followed by dry lint free cloth. 3.5 Clean the body of the machine with dry lint free cloth. 3.6 Remove ‘TO BE CLEANED’ label and affix ‘CLEANED’ (LBPR:xxxx) to the machine. 3.7 Fill the Equipment Cleaning checklist (QAP:xxxx). 3.8 Enter the details in the ‘Equipment usage log’ (SOP: PRGN:xxxxx)

1.0 SCOPE: Applicable to Blister Pack Machine (Pharmapack 240 SS) manufactured by Precision Gears Ltd. 2.0 RESPONSIBILITY: Operator, Production Officer. 3.0 PROCEDURE: 3.1 AT THE TIME OF BATCH CHANGE OVER / AT THE END OF SHIFT 3.1.1 Ensure that the machine labeled as ‘TO BE CLEANED’ (LBPR:xxx). Enter the details in the ‘Equipment usage log’ (PRGN:xxxx). 3.1.2 Switch ‘OFF’ the main power supply to the machine. 3.1.3 Close compressed air valve and cooling water for the machine. 3.1.4 Compressed air should not be used for cleaning blister pack machine. 3.1.5 Remove overprinting polymer stereos/coding metal stereos (whichever is applicable) of previous batch. Destroy the polymer stereos by cutting into pieces/give the metal stereos to the concerned Production Officer (whichever is applicable) . Incase part batch is packed, retain the stereos. Record the same in Batch Packing Record. 3.1.6 Clean the ink pelt with a lint free cloth dipped in thinner (if applicable). 3.1.7 ...

1.0 SCOPE: Applicable to Automatic Capsule Filling (AF-90T) Machine manufactured by Pam Pharmaceutical and Allied Machinery Company Limited. 2.0 RESPONSIBILITY: Operator, Production Officer. 3.0 PROCEDURE: 3.1 AT THE TIME OF BATCH CHANGE OVER / AT THE END OF SHIFT 3.1.1 Ensure that the machine labeled as ‘TO BE CLEANED’ (LBPR:xxxx). Enter the details in the ‘Equipment usage log’ (PRGN:xxxx). 3.1.2 Switch ‘ON’ the main power supply to the machine. 3.1.3 Clean the machine with vacuum cleaner to remove the empty capsules. 3.1.4 Clean the machine with vacuum cleaner to remove the powder from the platform. 3.1.5 Clean the empty capsule hopper with dry lint free cloth. 3.1.6 Clean the powder hopper inside using vacuum cleaner and outside with dry lint free cloth. 3.1.7 Clean the slug collection box using vacuum cleaner. 3.1.8 Clean the machine body, acrylic doorframes, acrylic doors and the top of the machine with dry lint free cloth. 3.1.9 Remove ‘TO BE CLEANED’ la...

1.0 SCOPE: Applicable to Air Displacement Unit (ADU-100) manufactured by Pam Pharmaceutical and Allied Machinery Company Limited. 2.0 RESPONSIBILITY: Operator, Production Officer. 3.0 PROCEDURE: 3.1 AT THE TIME OF BATCH CAHNGE OVER / AT THE END OF SHIFT 3.1.1 Ensure that the machine labeled as ‘TO BE CLEANED’ (LBPR:xxx). Enter the details in the ‘Equipment usage log’ (PRGN:xxxx). 3.1.2 Check that the machine is switched ‘OFF’. 3.1.3 Remove the top cover along with the filter bag assembly and sucker rod of the machine by removing the four toggle clamps. 3.1.4 Remove the rubber seal ring and the hosepipes. 3.1.5 Remove the filter bag and clean the filter bag of ADU-100 machine with help of compressed air at service floor. 3.1.6 Clean the powder-collecting chamber using vcuum cleaner. 3.1.7 Wipe the hosepipes with dry lint free cloth. 3.1.8 Wipe the outer body of the machine with dry lint free cloth. 3.1.9 Fix the filter bag on the shaker assembly. 3.1.10 Place ...

1.0 SCOPE: Applicable to all the accessories used in the production area. 2.0 RESPONSIBILITY: Operator, Production Officer. 3.0 PROCEDURE: 3.1 Keep all the accessories on a SS Table trolley and label the trolley as ‘TO BE CLEANED’ (LBPR:xxx) and transfer the trolley in the washing area. Clean the accessories as per the following procedure. 3.2 Dry all the accessories using dry lint free cloth and keep them on SS Table trolley. 3.3 Remove ‘TO BE CLEANED’ label and affix ‘CLEANED’ (LBPR:xxxx) to the trolley. 3.4 Keep the accessories in a polyethylene bag and put the ‘CLEANED’ (LBPR:xxxx) label.

1.0 SCOPE: To provide guidelines to ensure effective line clearance of the area and equipment. 2.0 RESPONSIBILITY: Operator, Production Officer. 3.0 PROCEDURE: 3.1 Ensure that the area is cleaned as per SOP: PRGN:xxxx 3.2 Ensure that Vacuum cleaner is cleaned as per the SOP: PRCL:xxxx; Point No: 3.1 for Batch change over/At the end of shift or is cleaned as per the SOP: PRCLxxxx; Point No: 3.2, for Product change over/Expiry of use before date. 3.3 Ensure that all containers, documents and labels of previous product / batch are removed and status board is updated. 3.4 Ensure that all the cervices and near by area is free from previous product. 3.5 Ensure that all the gloves and accessories of previous product/batch are removed. 3.6 Check the Temperature, Relative Humidity and the Differential Pressure of the cubicle and enter the same in the Batch Manufacturing / Packing Record. 3.7 Line clearance is given by Production Officer to start the next batch, after checkin...

1.0 SCOPE: To provide guidelines to ensure effective line clearance of the area and equipment. 2.0 RESPONSIBILITY: Operator, Production Officer. 3.0 PROCEDURE: 3.1 Ensure that the area is cleaned as per SOP: PRGN:xxxx 3.2 Ensure that Try dryer is cleaned as per the SOP: PRCL:xxxx; Point No: 3.1 for Batch change over/At the end of shift or is cleaned as per the SOP: PRCL:xxxx; Point No: 3.2, for Product change over/Expiry of use before date. 3.3 Ensure that all containers, documents and labels of previous product / batch are removed and status board is updated. 3.4 Ensure that all the cervices and near by area is free from previous product. 3.5 Ensure that all the gloves and accessories of previous product/batch are removed. 3.6 Ensure that gloves and accessories box is cleaned. 3.7 Check the Temperature, Relative Humidity and the Differential Pressure of the cubicle and enter the same in the Batch Manufacturing Record. 3.8 Line clearance is given by Production Of...