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
“Pinhole Detector” is used in pharmaceuticals to detect a hole in lidding foil/aluminum foil. Sometimes, it is not possible to detect the small hole with the naked eyes that is present in foil. So, to detect these types of holes, a pinhole unit is installed between the forming station and the feeding channel of a … Read more
1.0 Purpose: To lay down the procedure for receiving, handling, and storage of primary and secondary packaging Material. 2.0 Aim: This Standard Operating procedure is applicable to the receiving, handling, and storage of primary and secondary packaging material on the production floor. 3.0 Responsibility:3.1 The line coordinators shall carry out the process.3.2 Officers/ Sr. officers … 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
Sometimes we may confused when it comes to understanding the difference between moisture content and Loss on Drying (LOD). To clear your doubts, please read the entire section of this post. Firstly, let’s discuss about moisture analyzers. A moisture analyzer is used to determine the water content in a sample. Then a few questions arise … Read more
1.0 Scop: To laydown procedure on Cleaning And Operation Of Dynamic Pass Boxes.2.0 Aim: This SOP is applicable for cleaning and operation dynamic pass boxes (GMP Make) located in various Production, QC, and warehouse rooms. 3.0 Responsibility:3.1 Asst. Manager/ Sr. Officer / Officer/Line coordinator shall execute this SOP.3.2 Manager / Sr. Manager Shall supervise that the process is being … Read more
A Metal detector is used to find out and remove small pieces of ferrous, non-ferrous, and SS during tablet compression in pharmaceuticals. Many times, Such types of metal may be entered into the product during the process, for example, worm sieve wires. This is where the metal detector comes into the role to removes such types of … Read more
1.0 Purpose: To lay down the procedure for cleaning & operation of peristaltic pump.2.0 Aim: This Standard Operating Procedure applies to the peristaltic pump on the production floor. 3.0 Responsibility:3.1 The trained Line Coordinator will be responsible for the operation of the peristaltic pump.3.2 Officers / Sr. officers will supervise the process.3.3 Production Manager will be responsible for … Read more