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
1.0 Purpose: To describe the procedure for design, print, issuance, and control logbooks for equipment/ instruments and documents.2.0 Aim: This Standard Operating Procedure is applicable to design, print, maintain, issue, and control the equipment/instrument or document logbooks about all activities in the Production department. 3.0 Responsibility:3.1 Printing and procurement of logbooks shall be done by … Read more
1.0 Objective: To lay down a procedure for cleaning of conveyor belt.2.0 Scope: This Standard Operating procedure is applicable to the cleaning of conveyor belt used in the production department.3.0 Responsibility:Officer – To follow this procedureManager – To ensure overall compliance with this Procedure 4.0 Procedure for Cleaning Of Conveyor Belt: 4.1 TYPE A Cleaning … Read more
1.0 OBJECTIVE: To lay down a procedure for the reconciliation & destruction of packing materials.2.0 SCOPE: This Standard operating procedure is applicable to the reconciliation & destruction of packing materials in the production area.3.0 RESPONSIBILITY:Officer, and Executive – to follow procedure.Manager – Production Department- overall compliance with this SOP. 4.0 PROCEDURE: 4.1 Batch-wise reconciliation shall … Read more
1.0 Purpose: To lay down a procedure for the preparation of Aluminum Seals.2.0 Aim: This Standard operating procedure is applicable for the preparation of Aluminum Seals in the Production area. 3.0 Responsibility:3.1 The line coordinators who are trained in the processes shall carry out the operation process.3.2 Officer / Sr. Officer shall supervise the process.3.3 … Read more
1.0 Purpose: To lay down the procedure for removal of broken down equipment and taking the repaired equipment back into the facility.2.0 Aim: This Standard Operating Procedure is applicable for the removal of broken down equipment and taking the repaired equipment back to the Production facility. 3.0 Responsibility:3.1 Line coordinators shall carry out the process.3.2 … Read more
1.0 Purpose: To lay down the procedure for receiving, handling, and storage of primary and secondary packaging Material. 2.0 Aim: This Standard Operating procedure is applicable to the receiving, handling, and storage of primary and secondary packaging material on the production floor. 3.0 Responsibility:3.1 The line coordinators shall carry out the process.3.2 Officers/ Sr. officers … Read more