cGMP and Regulatory Updates

1. OBJECTIVE: To lay down a standard operating procedure for Double cone Blender. 2. SCOPE: This procedure provides a standard method to operate and handle the Double cone Blender. 3. RESPONSIBILITY:  Machine operator.  Senior Chemist.  Head - Production. 4. PROCEDURE: 4.1. Make sure that Line clearance is duly checked and signed by QA Personal as per SOP No:P/P/048 4.2. Check and make sure that Double cone blender has been autoclaved. 4.3. Adjust the angle of the blender with the help of a moving wheel to a required position for convenience in loading the materials. 4.4. Load the materials from the container to the blender as per the sequence specified in the individual Batch Manufacture Record (BMR). 4.5. After loading the materials, close the lid of the blender. 4.6. Put the safety pin on the lid and fit it properly within its groove. Lock the blender lid by moving the wheel in clockwise direction. 4.7. Before starting the operation, ensure that the lid and the safety pin lock h...

1. Objective: To lay down a standard operating procedure for Semi-Automatic Liquid vial filling & Rubber stoppering Machine. 2. Scope: This procedure provides a standard method of operation and handling of the Automatic Liquid vial filling & Rubber stoppering Machine. 3. Responsibility: § Machine operator. § Senior Chemist. § Head - Production. 4. Procedure: 4.1. Check and make sure that entire machine parts are cleaned as per SOP No: P/P/012. 4.2. Make sure that Line clearance is duly checked and signed by QA Personal as per SOP No:P/P/047 4.3. Fill the solution to be filled, in the pressurized tank. 4.4. Connect the piston bottom hose to pressurized tank and piston top hose with the filling needles. 4.5. Adjust the speed of the conveyor according to the movement of piston in such a way that both speeds should be equal to avoid the spillage of the filling solution & break...

1. Objective: To lay down standard operating procedure for Dry heat sterilizer 2. Scope: This procedure provides a detailed method of operation and handling of the Dry heat sterilizer. 3. Responsibility: ¯ Operator. ¯ Senior Chemist. ¯ Head - Production. 4. Procedure: 4.1. Make sure that Line clearance is duly checked and signed by QA Personal as per SOP No:P/P/051 4.2. Wash the SS Box and clean the chamber of the dry heat sterilizer with DM water. 4.3. Run the sterilizer for half an hour by keeping the damper open after the first cleaning, to takeout all settled dust from its. 4.4. Turn off the sterilizer to clean the chamber by DM water with Non-fiber releasing cloth. 4.5. Place the load to be sterilized into the SS Box and put the SS Box back into the chamber of the dry heat sterilizer. 4.6. Close the pressure lock door, by pulling up the quick throw handle and turn the handle clockwise till the door is tig...

1. Objective: To lay down a Standard Operating Procedure for Labeling Machine 2. Scope: This procedure provides a Standard method of operation and handling of the Labeling Machine. 3. Responsibility: ¯ Operator. ¯ Senior Chemist. ¯ Head - Production. 4. Procedure: 4.1. Check and make sure that Line clearance is duly checked and signed by QA Personal as per SOP No: P/P/043. 4.2. Clean the machine with soft cloth. 4.3. Wash the Gum pot with 0.5% (v/v) Teepol solution followed by raw water. 4.4. Stick the Stereo’s with appropriate details like Batch. No., Mfg. Date, Exp. Date, and MRP on the printing master by means of the Gum tape. 4.5. Feed Ampoules/Vials on the Feeding Hopper, labels on the label Box and Gum in the Gum pot. 4.6. Spread Printing ink in the Ink roller. Switch on the Machine. 4.7. Hopper Roller transfers the Ampoules/Vials to be labeled from the Feeding Hopper to the Guide. 4.8. At the s...

1. Objective: To lay down a standard procedure for Filtration of Solution 2. Scope: This procedure provides a standard method of Filtration of Solution. 3. Responsibility: ¯ Senior Chemist. ¯ Head - Production. 4. Procedure: 4.1. Check and make sure that the area is clean & free from the previous product and any other materials related to previous products. 4.2. Wash and Autoclave the Membrane holder. 4.3. Place the membrane followed by 2-20 m prefilter in the 293mm membrane holder. 4.4. Connect the Nitrogen tube to the pressure vessel. 4.5. Connect the inlet and outlet tube of the membrane holder with pressure vessel and collection vessel respectively which has been already autoclaved. 4.6. Fill the solution to be filtered in the pressure vessel and pass the Nitrogen at the pressure of 3 to 4 kgs/cm 2 in the pressure vessel which will pump the solution to the membrane holder. 4.7. The solution will...

1. Objective: To lay down a standard operating procedure for Automatic injectable powder vial filling & rubber stoppering Machine. 2. Scope: This procedure provides a standard method of operation and handling of the Automatic injectable powder vial filling & Rubber stoppering Machine. 3. Responsibility: § Machine operator. § Senior Chemist. § Head - Production. 4. Procedure: 4.1. Check and make sure that Automatic Injectable Powder Vial and Rubber stoppering machine has been cleaned as per SOP No:P/P/011 4.2. Make sure that Line clearance is duly checked and signed by QA Personal as per SOP No:P/P/050 4.3. Make sure that the filling area has been cleaned properly. 4.4. Switch on the Laminar flow and make sure that it has been wiped with 70% IPA. 4.5. Receive the incoming sterilized, siliconised and dried containers on the unscrambler and suitably guided on to the moving woven conveyor belt at the...

1. Objective: To lay down a standard operating procedure for Automatic Ampoule Filling & Sealing Machine 2. Scope: This procedure provides a standard method of operation and handling of the Automatic Ampoule Filling & Sealing Machine. 3. Responsibility: § Machine Operator. § Senior Chemist. § Head - Production. 4. Procedure: 4.1. Check and make sure that Automatic Ampoule Filling and Sealing Machine has been cleaned as per SOP No: P/P/010 4.2. Make sure that Line clearance is duly checked and signed by QA Personal as per SOP No: P/P/044 4.3. Make sure that the filling area has been cleaned properly. 4.4. Switch on the Laminar flow and make sure that has been wiped with 70% IPA. 4.5. Feed the Ampoules to an inclined charging hopper from Sterilized S.S boxes. 4.6. The Ampoules are passed continuously through rotating feeding wheel, which in turn transfers the Ampoules positively to Ampoule...

1. Objective: To lay down a Standard Operating Procedure for Moist Heat Sterilizer with circular chart 2. Scope: This procedure provides a Standard method to operate the Moist Heat Sterilizer with circular chart. 3. Responsibility: v Operator. v Senior Chemist. v Head - Production. 4. Procedure: 4.1. Make sure that Line clearance is duly checked and signed by QA Personal as per SOP No:P/P/051 4.2. Open the pressure lock door by turning the handle anti-clockwise, till the quick throw handle easily pushed down. 4.3. Load the materials to be sterilized into the chamber by keeping the materials in trolley with proper labeling. 4.4. Close the pressure lock door by pulling up the quick throw handle, after which the handle is to be turned clockwise till it is reasonably tight. 4.5. Open the bypass valve of the moisture separator for 5 minutes to remove all the condensed water which is already present, from the line and the...