by Dr. Yashashwini Reddy | Aug 9, 2025
Out of Specification (OOS) Investigation in Pharmaceuticals Definition OOS results are test results that fall outside the pre-established acceptance criteria defined in specifications, procedures, or regulatory filings.They can occur in raw materials, in-process...
by Dr. Yashashwini Reddy | Aug 9, 2025
GMP Requirements in Pharmaceuticals Good Manufacturing Practice (GMP) is a regulatory framework ensuring that pharmaceutical products are consistently produced and controlled according to quality standards, minimizing risks to patients. 1. Quality Management System...
by Dr. Yashashwini Reddy | Aug 9, 2025
10 Tips for HPLC Analysis in Pharmaceuticals Choose the Right Column Select the correct stationary phase (C18, C8, phenyl, etc.) based on analyte polarity. Consider particle size, column length, and pore size for optimal separation. Prepare Mobile Phase Properly Use...
by Dr. Yashashwini Reddy | Aug 8, 2025
What Quality Really Means for Pharmaceuticals In the pharmaceutical industry, quality means ensuring that every medicine is safe, effective, and consistent, from raw materials to the final product delivered to patients. It is not just about meeting specifications —...
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...
