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
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 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 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 describe the procedure for the transfer of semi packed material to warehouse.2.0 Aim: This Standard Operating Procedure is applicable to the transfer of semi packed material from production to the warehouse.3.0 Responsibility:3.1 Officer Production3.2 Head production4.0 Safety considerations:4.1 Always keep the PFS tubs/vials in an upright position.4.2 Transfer the material immediately after … Read more
1.0 Purpose: To lay down the procedure for operation and cleaning of glass, vial/ Syringes crushing machine, and handling of crushed material.2.0 Aim: This Standard Operating Procedure is applicable for the operation and cleaning of glass crushing machines and handling of crushed material. 3.0 Responsibility: 3.1 Officer, and Executive – Production Department for implementation of … Read more
1.0 Purpose: To lay down the Procedure for the operation and cleaning of the bung processor.2.0 Aim: This Standard Operating Procedure is applicable to the operation and cleaning of bung processor equipment at the Production. 3.0 Responsibility:3.1 Trained line coordinators shall be responsible to carry out the operation as per SOP.3.2 Officer / Sr. Officer … Read more
Learn About Step by Steps Standard Operating Procedures for Vials Labeling Machines along with their Objective, Scope, Precaution, and Procedure. 1.0 OBJECTIVE: To lay down the procedure for operating of vials labeling machine.2.0 SCOPE: This SOP is applicable in the Department of Production for the Injection Section. 3.0 RESPONSIBILITIES:Head – Production for overall compliance with this SOPOfficer- Production for implementation tp … Read more
In this Standard Operating Procedure (SOP), we will discuss the proper procedures for cleaning and monitoring an aseptic area including; their Objective, Scope, Responsibility, Cleaning, and monitoring by Setting Plate Tests. 1.0 Objective: This SOP gives guidelines for cleaning and monitoring of aseptic area in the injection section of the production department 2.0 Scope: This SOP on Cleaning … Read more
Read about the Standard Operating procedure on DHS along with precautions, and DHS setting for Aspectic and Non-Aseptic areas. 1.0 Objective: To lay down a procedure for operation Dry Heat Sterilization (DHS) in the injection section. 2.0 Scope: This SOP on Dry Heat Sterilization is applicable to the Injection Section of the production department at the plant. 3.0 Responsibilities:Officer- Production for implementation … Read more
Learn about the Standard operating procedure on the vials washing machine in pharmaceuticals along with their Objective, Scope, Responsibility, procedure, precautions, cleaning, and acceptance criteria. 1.0 Objective: To lay down a procedure for Cleaning and operation of vials washing machine to make vials free from particulate matter.2.0 Scope: This SOP applies to the Injection Section of the production department. … Read more
Learn about the Standard procedure for the Sterilized Powder filling machine in the injection section along with their Objective, Scope, Responsibility, Procedure, and cleaning process. 1.0 Objective: To lay down the procedure for efficient Cleaning & Operation of the Sterilized Powder filling machine. 2.0 Scope: This SOP for Cleaning & Operation of a Sterilized Powder filling … Read more