SOP on Procedure for Coding Accessories

1.0 OBJECTIVE: To lay down a procedure for coding accessories.2.0 SCOPE: The procedure is applicable to the coding of accessories in the production department.3.0 RESPONSIBILITY:Officer, Executive – Production DepartmentManager – Production Department4.0 DEFINITION(S):Accessories: sieves, screens, FBD finger bag and RMG filter bag, scoops, blender bin, etc. in the production area. 5.0 PROCEDURE:5.1 Procedure to be … Read more

SOP on Operation of Tablet inspection belt

1.0 Objective: To lay down a procedure for the operation of a tablet inspection belt.2.0 Scope: This procedure is applicable to the operation of tablet inspection belt in production area.3.0 Responsibility:Operator, Officer, Executive – Production DepartmentManager – Production Department4.0 Definition:NA 5.0 Procedure:5.1 Operation:5.1.1 Ensure the cleanliness of equipment and area.5.1.2 After line clearance from QA, … Read more

SOP on Monoblock Filling and Sealing Machine

1.0 OBJECTIVE: To lay down the procedure for the Cleaning and Operation of the Monoblock Filling and Sealing Machine. 2.0 SCOPE: This procedure is applicable for the Cleaning and Operation of the Monoblock Filling and Sealing Machine in the liquid department. 3.0 RESPONSIBILITYOperator, Officer, Executive – Production and QA DepartmentManager – Production and QA Department … Read more

SOP on Online inspection of Washed empty / filled/ labeled bottles

SOP Online inspection

1.0 OBJECTIVE: To lay down a procedure for online inspection of washed empty / filled/labeled bottles during Liquid Orals filling and packing operation. 2.0 SCOPE: This procedure is applicable for online inspection of washed empty / filled/labeled bottles of all the Liquid dosage forms in Pharmaceuticals. 3.0 RESPONSIBILITY: Operator, Officer, Executive – Production DepartmentManager – … Read more

SOP; Preparation and Approval of Bill of material (BOM)

1.0 Purpose: To lay down a procedure for the preparation and approval of Bill of material (BOM).2.0 Applicable: This SOP is applicable for the preparation and approval of Bill of Material of different products manufactured at Pharmaceuticals.3.0 Responsibility:3.1 Designated person of Production shall be responsible for the preparation of bill of material for different products … Read more

SOP on Cleaning of Shipper Sealing machine

1.0 Objective: To lay down a procedure for cleaning of shipper sealing machine.2.0 Scope: This procedure is applicable to the cleaning of the shipper sealing machine in the production area.3.0 Responsibility: Officer, Executive – Production DepartmentManager – Production Department 4.0 Procedure: 4.1 TYPE A:Change over from one batch to the next batch of the same … Read more

SOP for Shifts Handover between the Shifts

1.0 OBJECTIVE: To lay down a procedure for shift handover between the Shifts.2.0 SCOPE: This standard operating procedure is applicable for shift handover between the Shifts in the production department.3.0 RESPONSIBILITY: Officer, Executive Production for implementation of this Procedure.Manager Production for Overall compliance with this SOP. 4.0 PROCEDURE:4.1 The following are the instructions to be … Read more

SOP on Operation of Bin Blender

1.0 Objective: To lay down a procedure for the operation of Bin Blender.2.0 Scope: This standard operating procedure Operation of Bin Blender is applicable to the Bin Blender located in the manufacturing area.3.0 Responsibility: Officer, Executive – Production Department follow procedure while executing the operationManager – Production Department for overall compliance 4.0 Procedure for Operation … Read more

SOP on Cleaning of Strip Pack Machine

1.0 OBJECTIVE: To lay down a procedure for cleaning of Strip Pack Machine.2.0 SCOPE: This procedure is applicable to the cleaning of strip pack machine in the3.0 RESPONSIBILITY: Operator, Officer, and Executive – Production DepartmentManager – Production Department 4.0 PROCEDURE :4.1 TYPE A Cleaning of Strip Pack MachineChange over from one batch to the next … Read more

SOP for Index Type Rotary Bottle Washing Machine

1.0 Objective: To lay down the procedure for the operation and cleaning of the Index Type Rotary Bottle Washing Machine.2.0 Scope: This Standard Operating Procedure for Bottle Washing Machine is applicable for the operation and cleaning of the Index Type Rotary Bottle Washing Machine in the liquid Oral department.3.0 Responsibility:Production Executive, Production Officer. 4.0 Procedure:4.1 … Read more

SOP for Operation & Calibration of pH Meter

1.0 Objective: To lay down the procedure for the Operation & Calibration of pH meter2.0 Scope: This sop of ph meter shall be applicable to the Analytical Development Department in Pharmaceuticals3.0 Reference: In-House4.0 Responsibility: Executive/Officer- Analytical Development5.0 Accountability: Manager-Analytical Development. 6.0 Procedure for pH meter, Make Lab India.:6.1 Cleaning Procedure for pH Meter:6.1.1 Clean the … Read more

SOP for Operation and Calibration of Dissolution Apparatus (Tester)

1.0 Objective: 1.1 To lay down the procedure for the Operation and Calibration of Dissolution Apparatus (Tester).2.0 Scope: 2.1 This SOP shall be applicable to the Analytical development at Pharmaceutical Analytical Lab.3.0 References: 3.1 In-House SOP of dissolution apparatus 4.0 Responsibility:4.1 AD Executive/Sr. Executive.4.2 To follow the procedure for calibration as per SOP.3.3 To maintain … Read more

SOP for Operation and cleaning of Tunnel sterilizer

1.0 Purpose: To lay down the procedure for the operation and cleaning of tunnel sterilizer.2.0 Aim: This Standard Operating Procedure is applicable for the operation and cleaning of depyrogenation tunnel installed in production.3.0 Responsibility:3.1 The line coordinators who are trained shall carry out the operation and cleaning process as per SOP.3.2 Officers/ sr. officers shall … Read more

SOP for Liquid tanks, Pipelines, and Filling machine

Blue SOP file for liquid tanks, pipelines, and filling machine placed on a stainless steel table inside a pharmaceutical production area, with stainless steel tanks and filling equipment visible in the background.

1.0 OBJECTIVE: To lay down the procedure for cleaning of Liquid tanks, Pipelines, and Filling machine. 2.0 SCOPE: This procedure is applicable for cleaning of Liquid tanks, Pipelines, and Filling machine in the liquid Oral department. 3.0 RESPONSIBILITY:Production Officer, Production Executive. 4.1 PROCEDURE: 4.1.1 Before starting the cleaning, check that the tank is empty and … Read more

SOP for Operation and Calibration of Analytical Balance

1.0 Objective: 1.1 To lay down the procedure for the Operation and Calibration of Analytical Balance (ISHIDA).2.0 Scope: 2.1 This SOP is applicable for the operation and calibration of Analytical Balance in Analytical Development labs.3.0 References: 3.1 In-house4.0 Responsibility:4.1 Executive/Officer Analytical Development Shall be responsible for the operation and calibration of the analytical balance.5.0 Accountability:5.1 … Read more

SOP on Pest & Rodent Control

1.0 Objective: To lay down the procedure for Pest & Rodent Control within the manufacturing areas.2.0 Scope: This pest & rodent control standard operating procedure within the manufacturing plant, factory areas and food industries.3.0 Responsibility: The housekeeping department officer/Executives is responsible for the implementation of this procedure.4.0 Accountability:QA Head shall be accountable for the implementation … Read more