by Dr. Yashashwini Reddy | Sep 2, 2025
1. Influence on Stability Moisture Sensitivity: Smaller granules have a larger surface area, which can increase moisture absorption, leading to hydrolytic degradation of moisture-sensitive drugs. Oxidation: Increased surface area also accelerates oxidative...
by Dr. Yashashwini Reddy | Sep 1, 2025
📘 Preparation of Master Formula Record (MFR) 📌 What is MFR? A Master Formula Record (MFR) is a controlled document that provides the recipe, manufacturing process, equipment, materials, and in-process controls required to produce a pharmaceutical product. It is...
by Dr. Yashashwini Reddy | Aug 28, 2025
1.0 Purpose To describe the procedure for the operation, monitoring, and data handling of data loggers used in the microbiology laboratory, controlled areas, warehouses, and cold storage rooms. 2.0 Scope This SOP applies to all data loggers used for monitoring...
by Dr. Yashashwini Reddy | Aug 28, 2025
1.0 Purpose To define the procedure for the proper operation, cleaning, and maintenance of the Sterile Dress Cabinet used for storing sterilized garments required for aseptic processing areas. 2.0 Scope This SOP applies to all sterile dress cabinets located in the...
by Dr. Yashashwini Reddy | Aug 28, 2025
1.0 Purpose To establish a procedure for the proper operation, calibration, and maintenance of the METONE Laser Particle Counter (LPC) used for monitoring airborne particulate contamination in controlled areas. 2.0 Scope This SOP applies to all personnel trained to...
