1.0 OBJECTIVE: To lay down a procedure for cleaning of paste preparation kettle.2.0 SCOPE: This SOP applies to the cleaning of the paste preparation kettle in the production area.3.0 RESPONSIBILITY:Operator, Officer, Executive –Production Department.Manager – Production Department. 4.0 PROCEDURE: This is a cleaning procedure for Change over of one batch to the next batch/ product … Read more
1.0 Purpose: To lay down the standard operating procedure for cleaning and operation of printing and rewinding machine for labels.2.0 Aim: This Standard Operating Procedure is applicable for cleaning and operation of printing and rewinding machines for labels.3.0 Responsibility:3.1 Trained line -Coordinators for cleaning and operation of the machine.3.2 Officers/ Sr. officers shall respectively supervise … Read more
1.0 Purpose: To lay down a procedure for Locations, limits, and frequency of nonviable particle count.2.0 Aim: This SOP is applicable to nonviable particle count locations, limits, and their frequency in the Production facility.3.0 Responsibility:3.1 Sr. Officer / Officer & line coordinator shall execute this SOP.3.2 In-charge / Head shall supervise that the process is … Read more
1.0 Purpose: To lay down the procedure for packing vials.2.0 Aim: This Standard Operating Procedure is applicable for packing vaccine vials in the Packing Section.3.0 Responsibility: 3.1 Trained operators and casual workers shall be responsible for packing activity.3.2 Officer/ Senior officer of Production shall be responsible for checking the activity.3.3 IPQA person shall be responsible … Read more
1.0 Purpose: To lay down the procedure for Receiving and Transfer the FGTN to Warehouse.2.0 Aim This Standard Operating Procedure is applicable to the packing Department in Pharmaceutical.3.0 Responsibility: 3.1 Trained operators/ line coordinators shall be responsible for receiving and transferring the material.3.2 Officer/Executives of production shall be responsible for checking the activity.3.3 IPQA in … Read more
1.0 Purpose: To lay down the standard operating procedure for cleaning and operation of carton coding machine.2.0 Aim: This SOP is applicable to the carton coding machines installed in the Production. 3.0 Responsibility:3.1 Line operator shall be responsible for cleaning and operation of carton coding machine3.2 Officer / Sr. Officer shall be responsible for supervising … Read more
1.0 Purpose: To describe the procedure for decontamination of used material that comes in contact with API.2.0 Aim: This Standard Operating Procedure is applicable for the decontamination of used material in the production department. 3.0 Responsibility: 3.1 Trained line coordinators shall carry out the decontamination process of used materials.3.2 Officers/Sr. Officers shall be responsible to … Read more
1.0 Objective: To lay down the procedure for handling filled bottles labeled with improper labels.|2.0 Scope:This procedure is applicable for filled bottles with improper labels in the liquid packing department in Pharmaceuticals3.0 Responsibility:Officer – Production department to implement this standard operating procedure.Manager- Production Department to overall compliance to this operating procedure 4.0 Procedure: 4.1 Types … Read more
1.0 Objective: To lay down a procedure for cleaning and operation of inspection unit for empty and filled bottles.2.0 Scope: This Standard operating procedure is applicable for cleaning and operation of the inspection unit for empty and filled bottles in the Liquid department. 3.0 ResponsibilityOperator, officer – Production departmentManager-QA, Production department 4.0 Procedure 4.1 Cleaning4.1.1 … Read more
1.0 Objective: To lay down a procedure for Cleaning utensils, SS accessories, and machine change parts.2.0 Scope: This procedure is applicable to cleaning utensils, SS accessories, and machine change parts in the Liquid orals department.3.0 Responsibility: Operator, Officer, Executive – Production DepartmentManager – Production Department 4.0 Procedure: 4.1 Cleaning Procedure of SS Accessories after every … Read more
1.0 Purpose: To lay down the procedure for operation and cleaning of glass, vial/ Syringes crushing machine, and handling of crushed material.2.0 Aim: This Standard Operating Procedure is applicable for the operation and cleaning of glass crushing machines and handling of crushed material. 3.0 Responsibility: 3.1 Officer, and Executive – Production Department for implementation of … Read more
1.0 Objective: To lay down a procedure for microbiological monitoring of compressed air used in manufacturing areas.2.0 Scope: This SOP shall be applicable for a total viable aerobic count of compressed air of “O” Zone and Class 10,000 (liquid manufacturing) area at Manufacturing area. 3.0 Responsibility:Execution: Tr. Executive and above –QC DepartmentChecking: Asst. Manager and … Read more
1.0 Objective: To lay down a procedure for the Verification of the sugar dissolving tank, manufacturing tank, and holding tank.2.0 Scope: The procedure is applicable to the verification of the sugar dissolving tank, manufacturing tank, and holding tank, installed in the Liquid orals Department. 3.0 ResponsibilityOfficer, and Executive – Production Department for implementation of this … Read more
1.0 Objective: To lay down a procedure for polishing punches and dies.2.0 Scope: This procedure is applicable to the polishing of punches and dies used in the production department.3.0 Responsibility:Officer, and Executive – Production Department for implementation of this procedure.Manager – Production Department for overall compliance with this procedure. 4.0 Procedure:4.1 Select the required brush … Read more
1.0 Objective: To lay down a procedure for change of the aluminum foil during packing.2.0 Scope: This standard operating procedure is applicable to the change of aluminum foil during packing in the production department.3.0 Responsibility: Officer, and Executive – Production Department for implementation of this procedure.Manager – Production Department for overall compliance with this procedure. … Read more
1.0 Objective: To lay down a procedure for the operation of the shipper sealing machine.2.0 Scope: This Standard operating procedure is applicable to the operation of the shipper sealing machines used in the production department.3.0 Responsibility:Officer, Executive – To follow this procedureManager – To execution this procedure 4.0 Procedure: 4.1 Machine Setting4.1.1 Ensure that the … Read more