1.0 Purpose: The purpose of this SOP is to provide instruction for the Retesting and Resampling of raw materials and intermediates.2.0 Objective: To provide a documented procedure for Retesting and Resampling of raw materials and intermediates.3.0 Scope: This procedure is applicable for the Retesting and Resampling of raw materials and intermediates in the QC department.4.0 … Read more
1.0 Purpose: To define the SOP for the Operation of a Stainless Steel Reactor.2.0 Scope: This procedure is applicable to the Operation of all stainless steel Reactor in the Production Department.3.0 Responsibility:Officer/Executive – Production.4.0 Accountability:Head – Production 5.0 Procedure:5.1 Check the “CLEANED” label is affixed to Reactor.5.2 Before starting the operation Check the calibration tags … Read more
1.0 Purpose: To lay down the procedure for cleaning and operating the Automatic strapping (banding) machine.2.0 Aim: This Standard Operating Procedure is applicable to the cleaning and operation of the automatic strapping (banding) machine Production floor. 3.0 Responsibility:3.1 The Line coordinators will carry out the cleaning and operation of the banding machine.3.2 Officer of the … Read more
1.0 Objective: To lay down the procedure for Sanitization of the Storage tank and Distribution Loopline and cleaning of DM and RO water storage tank.2.0 Scope: This procedure is applicable for the Sanitization of the Storage tank and Distribution Loopline and cleaning of DM and RO water storage tank in liquid oral department.3.0 Responsibility: 3.1 … Read more
1.0 Purpose: To describe the procedure for operation and cleaning of mobile SIP unit2.0 Aim: This Standard Operating Procedure is applicable for the operation and cleaning of mobile SIP unit.3.0 Responsibility: 3.1 The operator is responsible for operation and cleaning as per SOP.3.2 Officer/Executive shall supervise the process.3.3 Production manager for implementation of SOP.3.4 Head … Read more
1.0 Purpose: To lay down the procedure for the operation and cleaning of tray loading machine.2.0 Aim: This Standard Operating Procedure is applicable to the cleaning and operation of tray loading machine, located on the production floor.3.0 Responsibility:3.1 The line coordinators shall carry out the process.3.2 Officers/Executives shall be responsible to supervise the process.3.3 Production … Read more
1.0 Purpose: To lay down a procedure for the operation of Box Cutting and Vial loading.2.0 Aim: This Standard Operating Procedure is applicable to the operation of Box Cutting and Vial loading.3.0 Responsibility: 3.1 Trained operators shall be responsible for Box cutting and vials 3.2 Officers/Sr. Officer for working operation of Box Cutting and Vial … Read more
1.0 Purpose: To describe the procedure for tub handling of prefilled syringes of filling machine.2.0 Aim: This Standard Operating Procedure is applicable for tub handling of prefilled syringes of filling machine at Production.3.0 Responsibility:3.1 Officer Production3.2 Head Production4.0 Safety considerations:4.1 Handle the tubs with care while transferring them from one place to another place.4.2 Ensure … Read more
1.0 Purpose: To describe the procedure for cleaning and operation of vacuum scrubber.2.0 Aim: This Standard Operating Procedure is applicable to the cleaning and operation of vacuum scrubber present at the Production facility. 3.0 Responsibility:3.1 Officer / Sr. Officer & line coordinator shall execute this SOP.3.2 Head production to ensure implement this SOP.3.3 Head-QA shall … Read more
1.0 Purpose: To describe the procedure for the transfer of semi packed material to warehouse.2.0 Aim: This Standard Operating Procedure is applicable to the transfer of semi packed material from production to the warehouse.3.0 Responsibility:3.1 Officer Production3.2 Head production4.0 Safety considerations:4.1 Always keep the PFS tubs/vials in an upright position.4.2 Transfer the material immediately after … Read more
1.0 Purpose: To lay down a procedure for the preparation of rubber bungs.2.0 Aim: This Standard Operating Procedure is applicable for the preparation of rubber bungs. 3.0 Responsibility:3.1 Operator/ Sr. Operator is responsible for carrying out the operation process.3.2 Officers/Executives shall be responsible to supervise the process.3.3 Production-Head/Manager shall be responsible for the implementation of … Read more
1.0 Objective: To lay down a procedure for the Cleaning and Operation of conveyor belt and turn table. 2.0 Scope: This procedure is applicable to the Cleaning and Operation of conveyor belt and turn table in Liquid department. 3.0 ResponsibilityOperator, officer – Production Department 4.0 Procedure4.1 Cleaning4.1.1 Cleaning of conveyer belt4.1.1.1 Start the conveyor belt … Read more
1.0 Objective: To lay down the procedure for the cleaning, Operation of Labeling machine.2.0 Scope: This procedure is applicable to the cleaning, operation of Labeling machine in liquid packing section.3.0 Responsibility: Production Officer, Production Incharge to follow this SOPHead of Department for overall compliance to this SOP. 4.0 Cleaning4.1 General Points:4.1.1 Stop the machine by … Read more
1.0 Objective: To lay down the procedure for Bottle Inspection.2.0 Scope: This procedure is applicable to Bottle Inspection in the liquid department.3.0 Responsibility: Production Executive, Production Manager. 4.0 Procedure:4.1 Before Filling:4.1.1 Receive the washed bottles in the pre-filling inspection box.4.1.2 Inspect the bottles on an optical inspection box consisting of a 60-watt bulb mounted on … Read more
1.0 Objective: To lay down the procedure for Calibration of Dipstick.2.0 Scope: This procedure is applicable for the Calibration of Dipstick in the Liquid Oral department.3.0 Responsibility: Production Officer, Production Executive. 4.0 Procedure:4.1 Take a Plastic bin having about 70 liters capacity and tare it on a suitable calibrated balance.4.2 Fill purified water at 25°C … Read more
1.0 Objective: To lay down a procedure for the sanitization of drain points in pharmaceuticals.2.0 Scope: The procedure is applicable to drain point sanitization in the production area at pharmaceutical companies. 3.0 Responsibility: Housekeeping personnel is to follow this procedure.officers, Executives are responsible to implement this SOP.Manager – Production Department responsible for Overall compliance with … Read more