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 2, 2025
Spillage Management in Pharmaceutical Production Area Spillages in pharmaceutical production areas can pose serious risks including contamination, product quality compromise, safety hazards, and regulatory non-compliance. Effective spillage management ensures product...
by Dr. Yashashwini Reddy | Aug 28, 2025
1.0 Purpose To describe the procedure for physical monitoring of the microbiology section to ensure compliance with Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and regulatory requirements. 2.0 Scope This SOP applies to all physical parameters...
by Dr. Yashashwini Reddy | Aug 28, 2025
1.0 Purpose To define the procedure for proper handling, storage, usage, and disposal of biological indicators (BIs) used to monitor and validate sterilization processes (steam, dry heat, ethylene oxide, hydrogen peroxide, etc.). 2.0 Scope This SOP applies to all...
by Dr. Yashashwini Reddy | Aug 18, 2025
Writing Effective SOPs in Pharmaceuticals Standard Operating Procedures (SOPs) are the backbone of pharmaceutical operations, ensuring consistency, compliance, and quality across all processes. An effective SOP must be clear, concise, and compliant with GMP (Good...
