by Dr. Yashashwini Reddy | Aug 8, 2025
User Requirement Specification (URS) of Equipment 1. Definition The URS is a document prepared by the end user that clearly defines the functional, operational, and regulatory requirements an equipment must meet before procurement or qualification.It serves as a...
by Dr. Yashashwini Reddy | Aug 8, 2025
Steps for HPLC Method Development 1. Define the Purpose Identify the analyte(s) to be separated and quantified. Define method requirements (accuracy, precision, sensitivity, run time). 2. Gather Information Chemical structure, polarity, pKa, solubility of the analyte....
by Dr. Yashashwini Reddy | Aug 8, 2025
Investigation of OOS Results in Analytical Testing 1. What is an OOS Result? An Out-of-Specification (OOS) result is any analytical test result that falls outside the established acceptance criteria/specifications outlined in an approved method, regulatory filing, or...
by Dr. Yashashwini Reddy | Jun 9, 2025
Sampling in Cleaning Validation in Pharmaceutical Industry Cleaning Validation is a crucial part of pharmaceutical manufacturing to ensure that equipment and production areas are properly cleaned to prevent cross-contamination, ensure product quality, and comply with...
by Dr. Yashashwini Reddy | May 13, 2025
Standard Operating Procedure (SOP) Here is a complete Standard Operating Procedure (SOP) for Operation and Cleaning of Co-Mill (Cone Mill)—a commonly used equipment in the pharmaceutical industry for particle size reduction and granule uniformity. This...
