by Dr. Yashashwini Reddy | Aug 18, 2025
📋 Procedure for Sampling in Process Validation 1. Preparation Stage Review the approved Process Validation Protocol for sampling details (points, number of samples, method). Ensure that sampling tools and containers are clean, calibrated, and labeled. Train personnel...
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...
by Dr. Yashashwini Reddy | Aug 18, 2025
Revalidation of Pharmaceutical Processes Revalidation in pharmaceuticals refers to the documented evidence that an established process continues to operate in a state of control and consistently produces a product meeting predetermined specifications and quality...
by Dr. Yashashwini Reddy | Aug 18, 2025
Gap Analysis for Regulatory Compliance Gap Analysis is a structured approach used in pharmaceutical and life sciences industries to identify the differences (“gaps”) between current practices and regulatory requirements or industry standards (e.g., FDA, EMA, ICH,...
by Dr. Yashashwini Reddy | Aug 18, 2025
Quality Inspection in Pharmaceuticals Quality inspection in pharmaceuticals is a critical step to ensure that drug products meet regulatory standards, patient safety requirements, and therapeutic efficacy. It involves systematic checks, tests, and verification across...
