1.0 Objective: To lay down a procedure for cleaning and operation of inspection unit for empty and filled bottles.2.0 Scope: This Standard operating procedure is applicable for cleaning and operation of the inspection unit for empty and filled bottles in the Liquid department. 3.0 ResponsibilityOperator, officer – Production departmentManager-QA, Production department 4.0 Procedure 4.1 Cleaning4.1.1 … Read more
Track and trace system in pharmaceuticals is a process of determining the current and past history of products through their unique ID, or their properties. It helps the manufacturer to get information about false or copied products in the market. Track system is simply to know about the current and past location of any serialized … Read more
1.0 Objective: To lay down a procedure for Cleaning utensils, SS accessories, and machine change parts.2.0 Scope: This procedure is applicable to cleaning utensils, SS accessories, and machine change parts in the Liquid orals department.3.0 Responsibility: Operator, Officer, Executive – Production DepartmentManager – Production Department 4.0 Procedure: 4.1 Cleaning Procedure of SS Accessories after every … Read more
Both humidity and relative humidity refer to the amount of water vapour in the air, however, they are not the same. Humidity is the absolute amount of water vapour in the air, whereas relative humidity is the amount of water vapour in the air in comparison to the maximum amount of water vapour the air might … 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
The BQS (Blister Quickly Through Servo) Machine is a part of pharmaceutical packaging, where it helps to aggregate unit doses into a blister form, also known as primary packaging. BQS uses continuous motion technology, enabled by flat sealing and flat forming, to achieve precision, power, speed, and position control. BQS machine Change Parts Principle of … Read more
1.0 Objective: To lay down a procedure for microbiological monitoring of compressed air used in manufacturing areas.2.0 Scope: This SOP shall be applicable for a total viable aerobic count of compressed air of “O” Zone and Class 10,000 (liquid manufacturing) area at Manufacturing area. 3.0 Responsibility:Execution: Tr. Executive and above –QC DepartmentChecking: Asst. Manager and … Read more
Hold time is the period during which materials ( Machine Parts) may be held under specified conditions or time and remain within the stipulated requirements. At all phases of production Hold time study on machine change parts to be done on a given frequency to ensure the quality of products. Manufacturers must ensure that the … Read more
1.0 Objective: To lay down a procedure for the Verification of the sugar dissolving tank, manufacturing tank, and holding tank.2.0 Scope: The procedure is applicable to the verification of the sugar dissolving tank, manufacturing tank, and holding tank, installed in the Liquid orals Department. 3.0 ResponsibilityOfficer, and Executive – Production Department for implementation of this … Read more
1.0 Objective: To lay down a procedure for polishing punches and dies.2.0 Scope: This procedure is applicable to the polishing of punches and dies used in the production department.3.0 Responsibility:Officer, and Executive – Production Department for implementation of this procedure.Manager – Production Department for overall compliance with this procedure. 4.0 Procedure:4.1 Select the required brush … Read more
1.0 Objective: To lay down a procedure for change of the aluminum foil during packing.2.0 Scope: This standard operating procedure is applicable to the change of aluminum foil during packing in the production department.3.0 Responsibility: Officer, and Executive – Production Department for implementation of this procedure.Manager – Production Department for overall compliance with this procedure. … Read more
Today’s Countless tablets and pills are being produced worldwide by using different methods. Choosing an appropriate method for formulation depends on the types of materials that are going to add while making granules, For example for some heat-sensitive materials, Generally, Direct compression method is used. Below is a detailed discussion on Different types of tablets … Read more
1.0 Objective: To lay down a procedure for the operation of the shipper sealing machine.2.0 Scope: This Standard operating procedure is applicable to the operation of the shipper sealing machines used in the production department.3.0 Responsibility:Officer, Executive – To follow this procedureManager – To execution this procedure 4.0 Procedure: 4.1 Machine Setting4.1.1 Ensure that the … Read more
Most pharmaceutical manufacturing companies have realized that in order to achieve the goal of long-term business survival in today’s regulated environment, they need to install a full eMES system, also known as the eBMR system. However, the current infrastructure situation prevents such an implementation from proceeding. Before discussing the difference between BMR/BPR and eBMR, it … Read more
Many of the gases, liquids, and powders utilized in pharmaceutical product formulation are extremely flammable, explosive, reactive, and/or poisonous. So Fire Safety Practices must be followed to ensure the overall safety of pharmaceuticals. Furthermore, many of the processes used in pharmaceutical plants – from delivery through reactor processing to filtration, drying, milling /micronizing, combining, and … Read more
1.0 Purpose: To describe the procedure for design, print, issuance, and control logbooks for equipment/ instruments and documents.2.0 Aim: This Standard Operating Procedure is applicable to design, print, maintain, issue, and control the equipment/instrument or document logbooks about all activities in the Production department. 3.0 Responsibility:3.1 Printing and procurement of logbooks shall be done by … Read more