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 affix the “UNDER … Read more
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
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
1.0 OBJECTIVE: 1.1 To lay down the procedure for the operation & calibration of water bath2.0 SCOPE: 2.1 This SOP is applicable to Analytical development at Pharmaceutical Lab.3.0 RESPONSIBILITY3.1 Officer/Executive – Analytical Development3.2 Manager-AD for overall compliance with this procedure4.0 ACCOUNTABILITY4.1 Manager-AD 5.0 PROCEDURE 5.1 Operating procedure5.1.1 Ensure that the instrument is clean and within … Read more
1.0 Purpose: To lay down the procedure for cleaning and storage of filling accessories.2.0 Aim: This Standard Operating Procedure is applicable to the cleaning and storage of filling accessories at the production department.3.0 Responsibility:3.1 Operator shall carry out the operation process.3.2 Officers shall be responsible to supervise the process.3.3 Head Production/ Designee shall be responsible … Read more
1.0 Objective: 1.1 To describe the procedure for Bills Realization. 2.0 Scope: 2.1 This procedure applies to the Purchase department in Pharmaceuticals. 3.0 Responsibility: 3.1 Asst. Manager- Purchase 4.0 Accountability:4.1 General Manager – Purchase in coordination with respective Department Heads like QC and Stores. 5.0 Procedure for Bill Realization 5.1 The nature of deviations may … Read more
1.0 Purpose: To lay down the procedure for the operation and cleaning of lyophilizer.2.0 Aim: This Standard Operating Procedure is applicable to the cleaning and operation of the Lyophilizer, located on the production floor.3.0 Responsibility:3.1 Officer Production3.2 Head Production 4.0 Safety considerations:4.1 Persons who are familiar with the basic safety and accident prevention regulations and … Read more
1.0 Purpose: To describe the procedure for auto-mode Sterilization of Piping System of blending Tanks.2.0 Aim: This Standard Operating Procedure is applicable to auto-mode Sterilization of Piping System of blending Tanks in solution preparation and formulation blending tanks. 3.0 Responsibility: 3.1 Officer/Executive line coordinator shall execute this SOP.3.2 Production Head/designee shall be responsible for implementation … Read more
1.0 Purpose: To lay down the procedure for manual visual inspection of filled vials.2.0 Aim: This Standard Operating Procedure is applicable for packing vaccines at the packing section. 3.0 Responsibility:3.1 Trained operators for visual inspection activities of vials.3.2 Officer is responsible for checking the activity.3.3 IPQA shall be responsible for compliance as per this SOP.3.4 … Read more
1.0 Purpose: To lay down the procedure for the operation of the particle counter2.0 Aim: This Standard Operating Procedure is applicable to the operation on the Production floor. 3.0 Responsibility:3.1 Line coordinators shall execute the process.3.2 Officer / Sr. Officer shall check & control the activity.3.3 Production Head shall be responsible for the execution of … Read more
1.0 Purpose: To describe the procedure for cleaning, sterilization, and operation of a Magnetic Stirrer.2.0 Aim: This Standard Operating Procedure is applicable for cleaning, sterilization, and operation of the Magnetic Stirrer.3.0 Responsibility:3.1 The line coordinator shall be responsible to carry out the procedure as per SOP.3.2 In-Charge/ Officer shall be responsible for checking and compliance … Read more
1.0 Objective: To describe the written standard procedure for the Operation & Calibration of HPLC LC- 2050C2.0 Scope: This SOP is applicable for the Operation & Calibration of HPLC LC-2050C3.0 Reference: In-House, Instrument Manual4.0 Responsibility: 4.1 Officers and Executive – F&D4.1.1 Proper Operation of HPLC, LC- 2050C4.1.2 Calibration as per frequency & method.4.1.3 To give … Read more
1.0 Objective: To lay down a procedure for the operation, calibration, and cleaning of the Electronic balance.2.0 Scope: This SOP is applicable for the operation & calibration of electronic balance in the Quality Control Department.3.0 Responsibility: Officer, Executive – Quality Control Department.Head – Quality Control Department 4.0 Procedure for Electronic balance:4.1 Operation4.1.1 Ensure the Calibration … Read more
1.0 Objective: To lay down the procedure for Cleaning and Operation of the basket filter assembly.2.0 Scope: This procedure is applicable for the Cleaning and Operation of the basket filter assembly in Liquid orals. 3.0 ResponsibilityOperator, – Production DepartmentOfficer, Executive- Production and QA DepartmentManager – Production and QA Department 4.0 Procedure4.1 Cleaning4.1.1 Remove the “ … Read more
1.0 Purpose: The purpose of this SOP for cleaning the glassware.2.0 Scope: This standard operating procedure is applicable to glassware in the Quality Control department at pharmaceuticals.3.0 ResponsibilityOfficer to implement this procedureHead QC/Executive – Responsible for overall compliance with this SOP.4.0 AccountabilityIn charge – Quality Control 5.0 Procedure5.1 Send the used glassware for cleaning after … Read more
Objective: To lay down procedures for validation of Analytical Procedures to be followed in the laboratory. The AMV (Analytical method Validation) aims to demonstrate that it is appropriate for the purpose.Scope: This SOP is applicable in Analytical Research and Development Laboratory (ADL) for validation or verification of analytical procedures at the Pharmaceutical Quality control laboratory. … Read more