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
1.0 Objective: To lay down a procedure for cleaning of conveyor belt.2.0 Scope: This Standard Operating procedure is applicable to the cleaning of conveyor belt used in the production department.3.0 Responsibility:Officer – To follow this procedureManager – To ensure overall compliance with this Procedure 4.0 Procedure for Cleaning Of Conveyor Belt: 4.1 TYPE A Cleaning … Read more
1.0 OBJECTIVE: To lay down a procedure for the reconciliation & destruction of packing materials.2.0 SCOPE: This Standard operating procedure is applicable to the reconciliation & destruction of packing materials in the production area.3.0 RESPONSIBILITY:Officer, and Executive – to follow procedure.Manager – Production Department- overall compliance with this SOP. 4.0 PROCEDURE: 4.1 Batch-wise reconciliation shall … Read more
Sikkim is a state located in northeast India, near the borders of Bhutan, Tibet, and Nepal The area, of the Himalayas, boasts a stunning environment including India’s tallest mountain Kangchenjunga at 8,586 meters. Glaciers, alpine meadows, and tens of thousands of different wildflowers can all be found in Sikkim. Hilltop Buddhist monasteries like Pemayangtse, built … Read more
Blister Film is a plastic processing technique that involves heating a flat plastic sheet, applying a vacuum to mold a surface, and then cooling the mold before filling it. This technique is widely used in plastic packaging, lighting, advertising, and decoration. However, issues related to the quality of blisters and defects in Pharmaceuticals may arise … Read more
1.0 Purpose: To lay down a procedure for the preparation of Aluminum Seals.2.0 Aim: This Standard operating procedure is applicable for the preparation of Aluminum Seals in the Production area. 3.0 Responsibility:3.1 The line coordinators who are trained in the processes shall carry out the operation process.3.2 Officer / Sr. Officer shall supervise the process.3.3 … Read more
1.0 Purpose: To lay down the procedure for removal of broken down equipment and taking the repaired equipment back into the facility.2.0 Aim: This Standard Operating Procedure is applicable for the removal of broken down equipment and taking the repaired equipment back to the Production facility. 3.0 Responsibility:3.1 Line coordinators shall carry out the process.3.2 … Read more