cGMP and Regulatory Updates

1.0 SCOPE: Applicable to Compression machine manufactured by Cadmach Machinery Company Pvt. Ltd. 2.0 RESPONSIBILITY: Operator, Production Officer. 3.0 PROCEDURE: 3.1 MACHINE AT THE TIME OF BATCH CHANGE OVER/ AT THE END OF SHIFT 3.1.1 Ensure that the machine labeled as ‘TO BE CLEANED’ Enter the details in the ‘Equipment usage log’ 3.1.2 Verify that the machine is switched ‘OFF’. 3.1.3 Change the status board of the cubicle. 3.1.4 Open the acrylic covers of the machine and suck the accumulated powder from the feed frame and other contact parts of the machine with the help of vacuum cleaner. 3.1.5 Open the cover of the De duster and clean it with vacuum cleaner. 3.1.6 Remove both the hoppers. Clean them with the help of vacuum cleaner followed by dry lint free cloth. 3.1.7 Suck the accumulated powder on the machine platform with the help of vacuum cleaner and clean the same with dry lint free cloth. 3.1.8 Remove both the feed frame and clean them using vacuum cleaner. 3.1.9 ...

1.0 SCOPE: Applicable to colloid mill manufactured by Bombay engineering company. 2.0 RESPONSIBILITY: Operator, Production Officer. 3.0 PROCEDURE: 3.1 Ensure that the machine labeled as ‘TO BE CLEANED’ Enter the details in the ‘Equipment usage log’ 3.2 Switch ‘OFF’ the main power supply to the machine. 3.3 Remove the hopper, recirculation assembly, ring, stator and rotor. 3.4 Clean the each part using about 30 kg of potable water followed by scrubbing with nylon scrubber dipped in 0.1% Sodium Lauryl Sulphate solution. 3.5 Clean the each part with about 30 kg of Potable water and finally rinse with about 30 kg of Purified Water. 3.6 Wipe the parts with dry lint free cloth and dry them using compressed air. 3.7 Clean the outer surface of the machine with the help of wet lint free cloth dipped in 0.1% Sodium Lauryl Sulphate solution followed by wet lint free cloth dipped in purified water. 3.8 Wipe it with a dry lint free cloth. 3.9 Assemble the hopper, recircula...

1.0 SCOPE: Applicable to Carton Over Printing machine manufactured by Nimach. 2.0 RESPONSIBILITY: Operator, Production Officer. 3.0 PROCEDURE: 3.1 Ensure that the machine labeled as ‘TO BE CLEANED’ Enter the details in the ‘Equipment usage log’ 3.2 Switch ‘OFF’ the main power supply to the machine. 3.3 Remove the coding stereos of previous batch / product and hand over the same to the concerned Production Officer. 3.4 Clean the ink roller with lint free cloth dipped in thinner. 3.5 Clean the machine with the help of wet lint free cloth followed by dry lint free cloth. 3.6 Clean the stereo roller with lint free cloth dipped in thinner. 3.7 Switch ‘ON’ the machine and take a blank run, if any abnormal sound is observed rectify the same prior to start. 3.8 Remove ‘TO BE CLEANED’ label and affix ‘CLEANED’ to the machine. 3.9 Fill the Equipment Cleaning Checklist 3.10 Enter the details in the ‘Equipment usage log’

1.0 SCOPE: Applicable to capsule inspection 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’ Enter the details in the ‘Equipment usage log’ 3.1.2 Switch ‘ON’ the machine. 3.1.3 Clean the hopper, vibratory pan, rejection collection box, and powder collection box and base tray with vacuum cleaner and wipe it with dry lint free cloth. 3.1.4 Clean the rollers with vacuum cleaner followed by dry lint free cloth. 3.1.5 Clean the body of the machine with dry lint free cloth. 3.1.6 Clean the control panel and the electrical connections with a dry lint free cloth. 3.1.7 Remove ‘TO BE CLEANED’ label and affix ‘CLEANED’ label to the machine. 3.1.8 Fill the Equipment Cleaning Checklist 3.1.9 Enter the details in the ‘Equipment usage log’ 3.2 AT THE TIME OF PR...

1.0 SCOPE: Applicable to bottle washing machine manufactured by Pharmalab. 2.0 RESPONSIBILITY: Operator, Production Officer. 3.0 PROCEDURE: 3.1 MACHINE AT THE TIME OF BATCH CHANGE OVER / AT THE END OF SHIFT. 3.1.1 Ensure that the machine labeled as ‘TO BE CLEANED’ Enter the details in the ‘Equipment usage log’ 3.1.2 Switch ‘OFF’ the main power supply to the machine. 3.1.3 Clean fiber sheet, transparent PVC sheets, Teflon bottle inverters, jet nozzles and interconnective hose pipes with the help of dry lint free cloth. 3.1.4 Clean bottle inverter holding plate, SS sheet with the help of dry lint free cloth. 3.1.5 Clean top cover and main body with the help of dry lint free cloth. 3.1.6 Clean control panel with the help of dry lint free cloth. 3.1.7 Clean tanks with the help of dry lint free cloth. 3.1.8 Remove ‘TO BE CLEANED’ label and affix ‘CLEANED’ to the machine. 3.1.9 Fill the Equipment Cleaning Checklist 3...

1.0 SCOPE: Applicable to the bottle drying machine manufactured by Metalchem Industries. 2.0 RESPONSIBILITY: Operator, Production Officer. 3.0 PROCEDURE: 3.1 MACHINE AT THE TIME OF BATCH CHANGE OVER / AT THE END OF SHIFT. 3.1.1 Ensure that the machine labeled as ‘TO BE CLEANED’ Enter the details in the ‘Equipment usage log’ 3.1.2 Switch ‘OFF’ the main power supply to the machine. 3.1.3 Open the door and remove the trolley and the trays out of the drying chamber. Clean them with the help of dry lint free cloth. 3.1.4 Clean the body (inside and outside) with the help of dry lint free cloth. 3.1.5 Clean the panel board, top portion and both the doors of the machine with the help of dry lint free cloth. 3.1.6 Remove ‘TO BE CLEANED’ label and affix ‘CLEANED’ to the machine. 3.1.7 Fill the Equipment Cleaning Checklist 3.1.8 Enter the details in the ‘Equipment usage log’ 3.2 AT THE TIME OF PRODUCT CHANGE OVER / EXPIRY ...

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:xxxxx 3.2 Ensure that the Conveyor Belt as per the SOP: PRCL: xxxxx 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 / batch. 3.5 Ensure that accessories of previous product/batch are removed. 3.6 Check the Temperature and Relative Humidity of the packing hall and enter the same in the Batch Packing Record. 3.7 Line clearance is given by Production Officer to start the next batch, after checking the above-mentioned points, which is to be recorded in the Batch Packing Record (BPR). 3.8 After checking all above points and the BPR, Final Line Clearance should be given by In Process Quality Assurance Officer....

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:xxxxx 3.2 Ensure that Colloid mill is cleaned as per the SOP: PRCL:xxxxx. 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 Record. 3.8 Line clearance is given by Production Officer to start the next batch, after checking the above-mentioned points, which is to be recorded in the Batch Manufacturing Record (BMR). 3.9 After checking all above points and the BMR, Final Line Clearance shoul...

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: PRGNxxxx. 3.2 Ensure that the Carton Overprinting Machine as per the SOP: PRCL: xxxxx. 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 accessories of previous product/batch are removed. 3.6 Line clearance is given by Production Officer to start the next batch, after checking the above-mentioned points, which is to be recorded in the Batch packing Record (BPR). 3.7 After checking all above points and the BPR, Final Line Clearance should be given by In Process Quality Assurance Officer. 3.8 Record the observations in the format PRLC:xxxxx 4.0 ENCLOSURE: 4.1 Line Clearance Checklist for Cart...

1.0 SCOPE: To provide the guidelines for the effective line clearance of the Capsule inspection machine. 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 the Capsule inspection belt is cleaned as per the SOP: PRCL:xxxxx; Point No: 3.1, for Batch change over/at the end of shift or as per the SOP: PRCL: xxxxx; 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 the balance is verified as per the SOP: QAGN:xxxx. 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 c...

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:xxxxx 3.2 Ensure that Bottle labeling machine is cleaned as per the SOP: PRCL:xxxxx 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 accessories of previous product/batch are removed. 3.6 Check the Temperature and Relative Humidity of the cubicle and enter the same in the Batch Packing Record. 3.7 Line clearance is given by Production Officer to start the next batch, after checking the above-mentioned points, which is to be recorded in the Batch Packing Record (BPR). 3.8 After checking all above points and the BPR, Final Line Clearance should be given by In Process Quality Assurance Offic...

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:xxxxx 3.2 Ensure that Bottle labeling machine is cleaned as per the SOP: PRCL:xxxxx 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 accessories of previous product/batch are removed. 3.6 Check the Temperature and Relative Humidity of the cubicle and enter the same in the Batch Packing Record. 3.7 Line clearance is given by Production Officer to start the next batch, after checking the above-mentioned points, which is to be recorded in the Batch Packing Record (BPR). 3.8 After checking all above points and the BPR, Final Line Clearance should be given by In Process Quality Assurance Offic...

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:xxxxx 3.2 Ensure that the Fluid Bed Dryer (Capacity-200 kg) is cleaned as per SOP: PRCL:xxxxx; Point No: 3.1, for batch change over/at the end of shift or as per SOP: PRCL: xxxxx; 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 the finger bag is cleaned and is of correct product. Check and record the integrity of the finger bag in the integrity checklist of the finger bag (PRCL:xxxxx) 3.6 Ensure that all the gloves and accessories of previous product/batch are removed. 3.7 Ensure that gloves and accessories box is cleaned. 3...

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:xxxxx 3.2 Ensure that the Elevator and tipper is cleaned as per SOP: PRCL:xxxxx 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 / batch. 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 Record. 3.7 Line clearance is given by Production Officer to start the next batch, after checking the above-mentioned points, which is to be recorded in the Batch Manufacturing Record (BMR). 3.8 After checking all above points and the BMR, Final Line C...

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 Empty capsule sorter machine is cleaned as per the SOP: PRCL:xxxxx; Point No: 3.1 for Batch change over/At the end of shift or is cleaned as per the SOP: PRCL:xxxxx 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 Record. 3.7 Line clearance is given by Production Officer to start the next batch, after c...

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.xxxxx. 3.2 Ensure that Dry syrup filling machine is cleaned as per the SOP: PRCL:xxxxx; Point No: 3.1 for Batch change over/At the end of shift or is cleaned as per the SOP: PRCL:xxxxx; 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/ batch. 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...

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:xxxxx. 3.2 Ensure that De-dusting and polishing machine is cleaned as per the SOP: PRCL:xxxxx; Point No: 3.1 for Batch change over/At the end of shift or is cleaned as per the SOP: PRCL:017/A; 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 Record. 3.7 Line clearance is given by Production Officer to start the next batch, ...

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:xxxxx 3.2 Ensure that the Tablet deduster is cleaned as per SOP: PRCL:xxxxx Point No: 3.1, for batch change over/at the end of shift or as per SOP: PRCL: xxxxx 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 Record. 3.7 Line clearance is given by Production Officer to start the next batch, after checking the above-mentione...

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:xxxxx. 3.2 Ensure that the Deblistering Machine as per the SOP: PRCL: xxxxx; Point No: 3.1, for batch change over/at the end of shift or as per SOP: PRCL: xxxxx; 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 containers, documents, labels, gloves and accessories of previous product/batch are removed and status displayed on the status board. 3.6 Check the Temperature, Relative Humidity and the Differential Pressure of the cubicle and enter the same in the Batch Packing Record. 3.7 Line clearance is given by Production O...

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:xxxxx 3.2 Ensure that the Conveyor Belt as per the SOP: PRCL: xxxxx 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 / batch. 3.5 Ensure that accessories of previous product/batch are removed. 3.6 Check the Temperature and Relative Humidity of the packing hall and enter the same in the Batch Packing Record. 3.7 Line clearance is given by Production Officer to start the next batch, after checking the above-mentioned points, which is to be recorded in the Batch Packing Record (BPR). 3.8 After checking all above points and the BPR, Final Line Clearance should be given by In Process Quality Assurance Officer....

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 the Compression Machine is cleaned as per the SOP: PRCL:xxxx; Point No: 3.1, for Batch change over/at the end of shift or 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 the punch set is fixed as per standard specification of respective product. 3.7 Check the cleanliness of the dedusting machine. 3.8 Check the Temperature, Relative Humidity and the Differential Pressure of the cubicle and e...

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 the Compression Machine is cleaned as per the SOP: PRCL: xxxx Point No: 3.1, for Batch change over/at the end of shift or 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 the punch set is fixed as per standard specification of respective product. 3.7 Check the cleanliness of the dedusting machine. 3.8 Check the Temperature, Relative Humidity and the Differential Pressure of the cubicle and e...

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 Colloid mill is cleaned as per the SOP: PRCL:xxxx. 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 Record. 3.8 Line clearance is given by Production Officer to start the next batch, after checking the above-mentioned points, which is to be recorded in the Batch Manufacturing Record (BMR). 3.9 After checking all above points and the BMR, Final Line Clearance should ...

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 the Carton Overprinting Machine as per the SOP: PRCL: xxxx. 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 accessories of previous product/batch are removed. 3.6 Line clearance is given by Production Officer to start the next batch, after checking the above-mentioned points, which is to be recorded in the Batch packing Record (BPR). 3.7 After checking all above points and the BPR, Final Line Clearance should be given by In Process Quality Assurance Officer. 3.8 Record the observations in the format PRLC:xxxx 4.0 ENCLOSURE: 4.1 Line Clearance Checklist for Carton...

1.0 SCOPE: To provide the guidelines for the effective line clearance of the Capsule inspection machine. 2.0 RESPONSIBILITY: Operator, Production Officer. 3.0 PROCEDURE: 3.1 Ensure that the area is cleaned as per SOP: PRGNxxxx 3.2 Ensure that the Capsule inspection belt is cleaned as per the SOP: PRCL:xxxx; Point No: 3.1, for Batch change over/at the end of shift or 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 the balance is verified as per the SOP: QAGN:xxxx. 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 clear...

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:xxx 3.2 Ensure that Bottle washing machine 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 Check the Temperature, Relative Humidity and the Differential Pressure of the cubicle and enter the same in the Batch Manufacturing Record. 3.7 Line clearance is given by Production Officer to start the next batch, after checking ...

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: PRGNxxxx. 3.2 Ensure that Bottle drying machine 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 Check the Temperature, Relative Humidity and the Differential Pressure of the cubicle and enter the same in the Batch Manufacturing Record. 3.7 Line clearance is given by Production Officer to start the next batch, after checking ...