SOP

1.0 OBJECTIVE: To lay down a procedure for making entries in equipment usage and cleaning log sheet.2.0 SCOPE: This procedure is applicable to making entries in equipment usage and cleaning log sheets in the production department.3.0 RESPONSIBILITY:Officer, Executive – Production DepartmentManager – Production Department4.0 DEFINITION(S):NA 5.0 PROCEDURE:5.1 Record the usage, cleaning, and preventive maintenance activity … Read more

1.0 Objective: The objective of this procedure is to provide guidelines for the operation of a Fluid Bed Dryer. 2.0 Scope: This procedure applies to the operation of the Fluid Bed Dryer located in the manufacturing area. 3.0 Responsibility: The Operator, Officer, and Executive of the Production Department, as well as the Manager of the … Read more

1.0 OBJECTIVE: To lay down a procedure for the operation of Rapid Mixer Granulator.2.0 SCOPE: This procedure is applicable to the operation of Rapid Mixer Granulator located in the manufacturing area.3.0 RESPONSIBILITY:Operator, Officer, Executive – Production DepartmentManager – Production Department4.0 DEFINITION(S):NA 5.0 PROCEDURE:5.1 Machine Setting:5.1.1 Ensure that the equipment and area are cleaned. Affix the … Read more

Objective: The objective of this procedure is to establish guidelines for operating a paste preparation kettle effectively. Scope: This procedure applies to the operation of the paste preparation kettle located in the manufacturing area. Responsibility: The responsibility for following this procedure lies with the Operator, Officer, and Executive of the Production Department, as well as … Read more

Objective: The objective of this procedure is to lay down the operation of the vibratory sifter Scope: This procedure applies to the operation of a vibratory sifter within the manufacturing area. Responsibility: The responsibility for following this procedure lies with the Operator, Officer, and Executive of the Production Department, as well as the Manager of … Read more

Aim: To lay down the Standard Operating Procedure (SOP) for Operating Laminar Airflow in a Microbiology Laboratory. Scope: This SOP applies to carry out the procedure for Operating Laminar Airflow in a Microbiology Laboratory. Safety precautions:a. Wear appropriate personal protective equipment (PPE), including a lab coat, gloves, and safety glasses.b. Do not obstruct the airflow by placing … Read more

1.0 OBJECTIVE: To lay down a procedure for the cleaning of production areas in Pharmaceuticals.2.0 SCOPE: The procedure is applicable to the cleaning of production area.3.0 RESPONSIBILITY: Housekeeping personnel, Operator production, Officer, Executive – Production DepartmentManager – Production Department4.0 DEFINITION(S):NA 5.0 PROCEDURE for Cleaning of Production area:5.1 Ceiling/ AHU grill /dust collector pipe:5.1.1 Frequency: Once … Read more

OBJECTIVE: To lay down the procedure for the Corrective and Prevention Action for non- conforming results in total microbial count in water samples SCOPE: This sop “Corrective and Prevention Action for non-conforming results” is applicable to the utility department and all the production department RESPONSIBILITY: Microbiologist Head – Microbiology Head – Production Block Head Engineering … Read more

1.0 Objective: To lay down the procedure for the operation and cleaning of Vernier Caliper.2.0 Scope: This procedure is applicable to the operation and cleaning of Vernier Caliper used in production department.3.0 Responsibility: Operator, Officer and Executive – Production DepartmentManager – Production DepartmentQA Officer – In Process4.0 Definitions:NA 5.0 Procedure:5.1 Operation:5.1.1 Ensure the cleanliness of … Read more

Purpose: SOP for Water System Validation to describe the steps to be followed for qualifying the water purification and distribution systemScope: Standard operating procedure for Water System Validation Applicable to all water purification and distribution systems installed in the facility.Responsibility: User DepartmentAccountability: Head of Validation Team. Procedure:Water Validation: Monitor the performance qualification of the water … Read more