1.0 Purpose: To describe the procedure for tub handling of prefilled syringes of filling machine.2.0 Aim: This Standard Operating Procedure is applicable for tub handling of prefilled syringes of filling machine at Production.3.0 Responsibility:3.1 Officer Production3.2 Head Production4.0 Safety considerations:4.1 Handle the tubs with care while transferring them from one place to another place.4.2 Ensure … Read more
1.0 Purpose: To describe the procedure for cleaning and operation of vacuum scrubber.2.0 Aim: This Standard Operating Procedure is applicable to the cleaning and operation of vacuum scrubber present at the Production facility. 3.0 Responsibility:3.1 Officer / Sr. Officer & line coordinator shall execute this SOP.3.2 Head production to ensure implement this SOP.3.3 Head-QA shall … 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 a procedure for the preparation of rubber bungs.2.0 Aim: This Standard Operating Procedure is applicable for the preparation of rubber bungs. 3.0 Responsibility:3.1 Operator/ Sr. Operator is responsible for carrying out the operation process.3.2 Officers/Executives shall be responsible to supervise the process.3.3 Production-Head/Manager shall be responsible for the implementation of … Read more
1.0 Objective: To lay down a procedure for the Cleaning and Operation of conveyor belt and turn table. 2.0 Scope: This procedure is applicable to the Cleaning and Operation of conveyor belt and turn table in Liquid department. 3.0 ResponsibilityOperator, officer – Production Department 4.0 Procedure4.1 Cleaning4.1.1 Cleaning of conveyer belt4.1.1.1 Start the conveyor belt … Read more
1.0 Objective: To lay down the procedure for the cleaning, Operation of Labeling machine.2.0 Scope: This procedure is applicable to the cleaning, operation of Labeling machine in liquid packing section.3.0 Responsibility: Production Officer, Production Incharge to follow this SOPHead of Department for overall compliance to this SOP. 4.0 Cleaning4.1 General Points:4.1.1 Stop the machine by … Read more
1.0 Objective: To lay down the procedure for Bottle Inspection.2.0 Scope: This procedure is applicable to Bottle Inspection in the liquid department.3.0 Responsibility: Production Executive, Production Manager. 4.0 Procedure:4.1 Before Filling:4.1.1 Receive the washed bottles in the pre-filling inspection box.4.1.2 Inspect the bottles on an optical inspection box consisting of a 60-watt bulb mounted on … Read more
1.0 Objective: To lay down the procedure for Calibration of Dipstick.2.0 Scope: This procedure is applicable for the Calibration of Dipstick in the Liquid Oral department.3.0 Responsibility: Production Officer, Production Executive. 4.0 Procedure:4.1 Take a Plastic bin having about 70 liters capacity and tare it on a suitable calibrated balance.4.2 Fill purified water at 25°C … Read more
1.0 Objective: To lay down a procedure for the sanitization of drain points in pharmaceuticals.2.0 Scope: The procedure is applicable to drain point sanitization in the production area at pharmaceutical companies. 3.0 Responsibility: Housekeeping personnel is to follow this procedure.officers, Executives are responsible to implement this SOP.Manager – Production Department responsible for Overall compliance with … Read more
In Industries, we always face confusion about the “Usage of expired Raw Materials” and “Retesting of expired raw materials” in the formulation of finished drug products. in this article, We will cover some Questions about Expired Raw and API materials in warehousing, as we have tried to explain them in a simple way. What is … Read more
Deviation from any process in pharmaceuticals can lead to a matter of investigation and root cause analysis. the manufacturer or responsible person shall be followed the following steps to do an investigation and root cause analysis by using corrective and preventive action. 1. Investigation/ Title for Root Cause Analysis: Start with the product’s name and … Read more
The procedure is applicable to the general procedure for filling the vaccine in the manufacturing area. Preparation of Primary packaging material for filling: Preparation of Filling Machine parts : Note: If required take the change over to the required format size 2ml, 3ml, or 5 ml format.Wash and prepare filling machine accessories and pack the … Read more
A tray dryer in the pharmaceutical industry is used to dry powders, granules, and other types of materials. It consists of a heated chamber with trays to place materials. The trays are usually stacked one on top of each other, and the drying process is usually done under controlled temperature and humidity conditions. It is … Read more
ICH Q10 guidelines basically mention the effective Pharmaceutical quality system (PQS). the pharmaceutical quality system is based on the ISO quality system including good manufacturing practice (GMP) regulations. Relationship Between ICH Q8, ICH Q9 and ICH Q10 Before the ICH Q10, ICH Q8 (Pharmaceutical development), and ICH Q9 (Quality risk management) were implemented throughout the … Read more
1.0 Purpose: To lay down the procedure for Washing, sterilization of clean room Garments2.0 Aim: This Standard Operating Procedure is applicable to the Washing, sterilization of clean room Garments in pharmaceuticals.3.0 Responsibility: 3.1 The line operator in operation processes shall carry out the operation process of Washing, and sterilization of clean room Garments.3.2 officers/seniors/executives shall … Read more
1.0 Purpose: To lay down the procedure for cleaning and preparation of filling machine accessories for sterilization.2.0 Applicable: This Standard Operating Procedure is applicable for the cleaning and preparation of filling machine accessories for sterilization on the Production Floor.3.0 Responsibility:3.1 The operator shall carry out the cleaning and preparation process.3.2 officers/Executives shall supervise the process.3.3 … Read more