by Dr. Yashashwini Reddy | Aug 18, 2025
Why Firms Must Avoid FDA 483 and Warning Letters? Pharmaceutical, biotechnology, and medical device firms must avoid FDA Form 483 observations and Warning Letters because they indicate serious compliance failures that can harm business operations, reputation, and...
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 18, 2025
Three Consecutive Batches for Validation in Pharmaceuticals In the pharmaceutical industry, process validation is a critical requirement to demonstrate that a manufacturing process consistently produces a product meeting predetermined quality attributes. Why three...
by Dr. Yashashwini Reddy | Aug 12, 2025
Quality Management System (QMS) 1. Definition A Quality Management System (QMS) is a structured framework of policies, procedures, processes, and resources that ensures pharmaceutical products consistently meet quality, safety, efficacy, and regulatory requirements.It...
by Dr. Yashashwini Reddy | Aug 9, 2025
Pharmaceutical Compliance and Product Quality 1. Pharmaceutical Compliance Definition:Adherence to all applicable laws, regulations, guidelines, and internal SOPs that govern pharmaceutical manufacturing, testing, storage, and distribution. Key Compliance Areas: GMP...
