by Dr. Yashashwini Reddy | Sep 5, 2025
1.0 Purpose To lay down the procedure for the operation, cleaning, and maintenance of the paste kettle to ensure uniform binder preparation in compliance with cGMP. 2.0 Scope This SOP applies to the paste kettle used in the production area for binder solution...
by Dr. Yashashwini Reddy | Sep 5, 2025
1.0 Purpose To establish a uniform procedure for the operation, cleaning, and maintenance of the conveyor belt used in the packing section to ensure smooth functioning and compliance with cGMP requirements. 2.0 Scope This SOP applies to all conveyor belts used in the...
by Dr. Yashashwini Reddy | Sep 2, 2025
🔹 1. Process Optimization Lean Manufacturing (Lean Pharma): Eliminate non-value-added steps, reduce waiting times, optimize material flow. Six Sigma & QbD (Quality by Design): Use statistical tools (DoE, risk assessment) to identify Critical Process Parameters...
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 30, 2025
Standard Operating Procedure (SOP) for Cleaning of Depyrogenation Oven 1.0 Purpose To establish a procedure for the cleaning of the hot air depyrogenation oven used for removal of pyrogens from glassware and equipment, ensuring compliance with cGMP requirements and...
