by Dr. Yashashwini Reddy | Sep 5, 2025
1.0 Purpose To establish a procedure for the operation, cleaning, and maintenance of the Saizoner Mixer Granulator to ensure uniform wet granulation in compliance with cGMP requirements. 2.0 Scope This SOP applies to the Saizoner Mixer Granulator installed in the...
by Dr. Yashashwini Reddy | Sep 5, 2025
1.0 Purpose To lay down the procedure for operation, cleaning, and maintenance of the Cage Blender to ensure uniform mixing of powders and granules in compliance with cGMP. 2.0 Scope This SOP applies to the Cage Blender installed in the production area of [Company...
by Dr. Yashashwini Reddy | Sep 3, 2025
Novel Drug Delivery Systems (NDDS) A Novel Drug Delivery System is a modern approach of formulating and delivering drugs to improve efficacy, safety, patient compliance, and targeted delivery compared to conventional dosage forms (like tablets, capsules, or...
by Dr. Yashashwini Reddy | Sep 3, 2025
Building Better Manufacturing Facilities in Pharmaceuticals Pharmaceutical manufacturing facilities must be designed to ensure product quality, patient safety, and regulatory compliance. A “better” facility goes beyond infrastructure—it integrates technology,...
by Dr. Yashashwini Reddy | Sep 2, 2025
🔹 Buffer Area in Sterile Facility 1. Definition The Buffer Area (also called the cleanroom or critical area) is a Class 100 / ISO 5 / Grade A-B environment where aseptic processing, sterile filling, and direct product exposure operations are performed. It is...
