1.0 Objective: To lay down a procedure for the movement of material from one stage to another.2.0 Scope: This procedure is applicable for the movement of material from one stage to another stage during various processes in the production department.3.0 Responsibility:Operator, Officer, and Executive – Production DepartmentManager – Production Department4.0 Definitions:NA 5.0 Procedure:5.1 Store to … Read more
1.0 Objective: To lay down the procedure for operation of Filter Press. 2.0 Scope: This procedure is applicable for the operation of the Filter Press in the liquid oral department. 3.0 Responsibility:Production Officer, Production Executive. 4.0 Procedure:4.1 Assembling: 4.1.1 The filter press consists of 9 sets of filter plates, mesh, and non-woven filter pads alternating … Read more
1.0 Objective: To lay down a procedure for monitoring temperature, relative humidity, and differential pressure in the production area.2.0 Scope: This procedure is applicable to the monitoring of temperature, relative humidity, and differential pressure in the production area.3.0 Responsibility: Officer, Executive – Production DepartmentManager – Production Department 4.0 Procedure:4.1 Recording of Temperature and relative humidity:4.1.1 … Read more
1.0 Objective: To lay down a procedure for Inventory and storage of sieves, screens. 2.0 Scope: This procedure is applicable to Inventory management and storage of sieves, screens. 3.0 Responsibility: Operator, Officer, Executive – Production DepartmentManager – Production Department 4.0 Procedure: 4.1 Inventory4.1.1 On intimation of receipt from stores, collect all the sieves/screens from the … Read more
1.0 OBJECTIVE: To lay down a procedure for cleaning of new equipment/machinery / in-process product containers/accessories received. 2.0 SCOPE: This procedure is applicable to the cleaning of new equipment/machinery / In-process product containers/accessories in the production department. 3.0 RESPONSIBILITY:Officer, Executive – Production DepartmentManager – Production Department 4.0 DEFINITION(S): Accessories: Sieves, screens. Spatulas, scoops SS jugs, … Read more
1.0 OBJECTIVE: 1.1 To define SOP on Change Control to be made in the authorized documents, validated methods, process, procedures, facilities, and equipment. 2.0 RESPONSIBILITY2.1 Assistant / Chemist / Executive – To initiate the Change Control Form.2.2 Respective Department Head – To evaluate and justify the required change.2.3 Other Departments Heads – To review and … Read more
1.0 OBJECTIVE: To lay down a procedure for handling products during a power failure in the production area.2.0 SCOPE: This procedure is applicable to the handling of products during a power failure in the production area.3.0 RESPONSIBILITY:Officer, Executive – Production Department, Quality AssuranceManager – Production Department, Quality Assurance4.0 DEFINITION(S):NA 5.0 PROCEDURE: 5.1 Action to be … Read more
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