Learn About SOP on Transfer and Receipt of bulk (Active Raw Materials) from the Warehouse to the Production area. 1.0 Purpose: To describe the procedure for transfer and receipt of bulk (Active Raw material) from the warehouse to the production area (Vaccine Formulation). 2.0 Applicable: This Standard Operating Procedure applies to the transfer … Read more
Learn About the Procedure for Thawing of Solution and Active Raw Material stored at or below -20 degrees C. 1.0 Purpose: To lay down the procedure for thawing of active raw material & solutions that are stored at or below -20 degrees C. 2.0 Applicable to: This Standard Operating Procedure is applicable for thawing of … Read more
Learn about Standard Operating Procedure on FBD Bag including their, Purpose, Scope, responsibility, Procedure for Indenting, Receiving, cleaning, storage, Issuance and Coding of FBD Bag. 1.0 Purpose: To lay down Standard Operating Procedure for Indenting, Receiving, Issuance, Coding, Usage, Cleaning, and Destruction of Fluidized-bed Dryer Bag.2.0 Scope: This SOP applies to all the FBD Bags used in the Tablet … Read more
Learn about Standard operating procedures on Preventive Maintenance of Auto Coater machines in Pharmaceutical industries. 1.0 Objective: To lay down a procedure for Preventive Maintenance of Auto Coater. 2.0 Responsibility: 2.1 Operator, and Officer to perform the preventive maintenance activities as per the respective SOP.2.2 Executives (Eng.Dept.) to prepare and comply with the preventive maintenance … Read more
1.0 Purpose: To describe the procedure for monitoring and recording critical environmental parameters of different classes at the production facility. 2.0 Aim: This Standard Operating Procedure is applicable for monitoring and Recording Critical Environmental Parameters such as temperature, relative humidity, pressure differential, and non-viable particle count of a different class (class A, B, C, and … Read more
1.0 Objective: The Purpose of this SOP is to lay down the procedure for the Operation and cleaning of the Domino Thermal Inkjet Printer. 2.0 Scope: This SOP is applicable for the Operation and Cleaning of the Domino Thermal Inkjet Printer at the manufacturing facility in Pharmaceuticals. 3.0 Responsibility:3.1 Operator Production shall be responsible for … Read more
1.0 Objective: The purpose of this SOP is to lay down the procedure for the Carton 2D Barcode Printing Machine. 2.0 Scope: This SOP is applicable for the Operation of a Carton 2D Barcode Printing Machine in a Manufacturing facility in Pharmaceuticals. 3.0 Responsibility:3.1 Operator Production shall be responsible for the operation of the Carton … Read more
Automatic Cartoning Machine is used for Packing blisters/Strips inside the carton in secondary packing areas in Pharmaceuticals. 1.0 Purpose: The purpose of this standard operating procedure is to lay down the procedure for Operation and Cleaning of Automatic Cartoning Machine (CP-150). 2.0 Scope: This SOP is applicable to the Operation and Cleaning of an Automatic … Read more
1.0 Aim: Procedure for Analysis and Release of Packaging Materials 2.0 Purpose: This standard operating procedure outlines the procedure for analyzing and releasing packaging materials at [company name]. 3.0 Scope: This procedure applies to the quality control laboratory and covers the analysis and release of packaging materials. 4.0 Responsibility:QC Analyst: Responsible for analyzing packaging materials.QC … Read more
1.0 Objective: To lay down a procedure for the return of excess packing material in production department to stores.2.0 Scope: This SOP is applicable for the return of excess packing material in production department to stores.3.0 Responsibility:Officer, Executive – Production DepartmentManager – Production Department4.0 Definitions:NA 5.0 Procedure:5.1 After completion of the packing activity, Reconcile the … Read more
1.0 Objective: To lay down a procedure for the management of sieves/ screens / FBD bowl mesh.2.0 Scope: The procedure is applicable to check the inventory and integrity of sieves/ screens / FBD bowl mesh in the production department.3.0 Responsibility:Officer, Executive – Production DepartmentManager – Production Department4.0 Definitions:NA 5.0 Procedure:5.1 For Inventory:5.1.1 On intimation of … Read more
1.0 Objective: To lay down a procedure for the cleaning of SS / HDPE containers, Inprocess containers (IPCs), Blender Bins, pallets, new sieve/screen, and accessories.2.0 Scope: This procedure is applicable for cleaning SS / HDPE containers, Inprocess containers (IPCs), Blender Bins, pallets, SS items, new sieve/screens, and accessories in the production department.3.0 Responsibility:Operator, Officer, Executive … Read more
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
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
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
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