1.0 Purpose: To describe the procedure for cleaning, sterilization, and operation of a Magnetic Stirrer.2.0 Aim: This Standard Operating Procedure is applicable for cleaning, sterilization, and operation of the Magnetic Stirrer.3.0 Responsibility:3.1 The line coordinator shall be responsible to carry out the procedure as per SOP.3.2 In-Charge/ Officer shall be responsible for checking and compliance … Read more
1.0 Objective: To describe the written standard procedure for the Operation & Calibration of HPLC LC- 2050C2.0 Scope: This SOP is applicable for the Operation & Calibration of HPLC LC-2050C3.0 Reference: In-House, Instrument Manual4.0 Responsibility: 4.1 Officers and Executive – F&D4.1.1 Proper Operation of HPLC, LC- 2050C4.1.2 Calibration as per frequency & method.4.1.3 To give … Read more
1.0 Objective: To lay down a procedure for the operation, calibration, and cleaning of the Electronic balance.2.0 Scope: This SOP is applicable for the operation & calibration of electronic balance in the Quality Control Department.3.0 Responsibility: Officer, Executive – Quality Control Department.Head – Quality Control Department 4.0 Procedure for Electronic balance:4.1 Operation4.1.1 Ensure the Calibration … Read more
1.0 Objective: To lay down the procedure for Cleaning and Operation of the basket filter assembly.2.0 Scope: This procedure is applicable for the Cleaning and Operation of the basket filter assembly in Liquid orals. 3.0 ResponsibilityOperator, – Production DepartmentOfficer, Executive- Production and QA DepartmentManager – Production and QA Department 4.0 Procedure4.1 Cleaning4.1.1 Remove the “ … Read more
1.0 Purpose: The purpose of this SOP for cleaning the glassware.2.0 Scope: This standard operating procedure is applicable to glassware in the Quality Control department at pharmaceuticals.3.0 ResponsibilityOfficer to implement this procedureHead QC/Executive – Responsible for overall compliance with this SOP.4.0 AccountabilityIn charge – Quality Control 5.0 Procedure5.1 Send the used glassware for cleaning after … Read more
Objective: To lay down procedures for validation of Analytical Procedures to be followed in the laboratory. The AMV (Analytical method Validation) aims to demonstrate that it is appropriate for the purpose.Scope: This SOP is applicable in Analytical Research and Development Laboratory (ADL) for validation or verification of analytical procedures at the Pharmaceutical Quality control laboratory. … Read more
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