by Dr. Yashashwini Reddy | Aug 18, 2025
How to Write a Validation Master Plan (VMP) A Validation Master Plan (VMP) is a high-level document that outlines a company’s overall philosophy, intentions, and approach for establishing performance qualification, validation, and compliance of its facilities,...
by Dr. Yashashwini Reddy | Aug 18, 2025
Recovery Factor Determination in Cleaning Validation Definition:Recovery Factor (RF) is the percentage of analyte recovered from a surface during cleaning validation studies. It helps to account for possible losses during swabbing/rinsing and analytical testing,...
by Dr. Yashashwini Reddy | Aug 12, 2025
Criteria to Choose the Correct Swab for Cleaning Validation Cleaning validation in pharmaceuticals ensures that residues from previous products, cleaning agents, or contaminants are effectively removed from manufacturing equipment to prevent cross-contamination.Swab...
by Dr. Yashashwini Reddy | Aug 12, 2025
CAPA Documentation: Common Mistakes to Avoid Definition:Corrective and Preventive Actions (CAPA) are processes used in pharmaceutical quality systems to investigate, address, and prevent the recurrence of deviations, non-conformances, or quality issues. Proper...
by Dr. Yashashwini Reddy | Aug 12, 2025
Change Control in Pharmaceuticals Definition:Change control is a formal GMP-compliant system used to manage and document any change in processes, equipment, materials, methods, documents, or facilities to ensure that product quality, safety, and regulatory...
