Pharma SOPs » Page 5 of 16

SOP on Withdrawal, Storage, Observation & Destruction of Control Sample

Standard Operating Procedure on Withdrawal, Storage, Observation & Destruction of Control/Retention Sample in Pharmaceuticals. 1.0 Objective: This SOP applies to the withdrawal, storage, observation, and destruction of control samples from production (OSD & Injectable) and Quality control (R.M. Retention) in the pharmaceutical formulation plant. 2.0 Scope: This Standard Operating Procedure applies to the withdrawal, storage, … Read more

SOP on Receipt and Handling of Laboratory Samples

1.0 OBJECTIVE: This procedure outlines the steps for receiving and Handling of Laboratory Samples. 2.0 SCOPE: This standard operating procedure pertains to the receipt and Handling of Laboratory Samples. 3.0 RESPONSIBILITY: The Quality Control Executive/Microbiologist is responsible for the implementation of this SOPThe Assistant Manager QC and/or QA Manager are responsible for Overall compliance with … Read more

SOP on Out of Acceptance Limit in Purified Water System

OBJECTIVE: To establish a procedure for action to be taken where critical parameters exceed acceptable limits within the purified water system. SCOPE: This Standard Operating Procedure applies to the generation and distribution of purified water systems. RESPONSIBILITY: Officer, Executive – Engineering Department.Head – Engineering Department for overall compliance to this SOP. ACCOUNTABILITY:Head of Engineering PROCEDURE: … Read more

SOP on Operation And Calibration Of Karl Fischer Apparatus

Aim: To provide Procedure on Operation And Calibration Of Karl Fischer Apparatus.Objective: This standard operating procedure explains how to use and calibrate the Karl Fischer apparatus.Responsibility: Chemist/Executive Q.C. for following this procedure.Accountability: The Manager of Quality Control is accountable for overall compliance with this SOP. Procedure: Cleaning Related SOP: SOP for Analysis and Release of … Read more

SOP for Analysis and Release of Packing Materials

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

SOP for HPLC Column Cleaning and their Maintenance

OBJECTIVE: To lay down a procedure for HPLC Column Cleaning and their Maintenance.SCOPE: This Standard operating procedure shall be applicable to HPLC Column Cleaning and maintenance of different types of HPLC columns used in the Quality Control Laboratory. RESPONSIBILITY: Officer/Execution QC department to follow this procedure.Manager QC department for overall compliance with this SOP. PROCEDURE … Read more

SOP on Return of Excess Packing material

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

SOP on Management of Sieves/ Screens / FBD bowl mesh

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

SOP on Procedure for the cleaning of SS / HDPE containers, Inprocess containers (IPCs), Blender Bins, pallets, new sieve / screen and accessories

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

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

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