by Dr. Yashashwini Reddy | Sep 15, 2025
4 Tips to Reduce 483 Observations The FDA issues Form 483 to highlight potential GMP violations observed during inspections. Minimizing these observations requires a proactive approach to compliance and quality culture. 1. Strengthen Documentation Practices Ensure...
by Dr. Yashashwini Reddy | Sep 15, 2025
Why Data Integrity is More Important Than Ever? Data integrity refers to the completeness, consistency, and accuracy of data throughout its lifecycle. In today’s highly regulated pharmaceutical and healthcare environment, data integrity has become more important than...
by Dr. Yashashwini Reddy | Sep 13, 2025
1. Equipment Design & Installation Equipment designed with GMP-compliant sanitary design (easy to clean, non-reactive materials). Materials of construction suitable (e.g., SS 316L for product contact). Installation Qualification (IQ) completed and documented....
by Dr. Yashashwini Reddy | Sep 13, 2025
GMP Audit Checklist – Process Validation 1. General Requirements Validation Master Plan (VMP) available, approved, and up to date. Validation activities aligned with regulatory guidelines (USFDA, EMA, WHO, ICH Q8–Q10). Validation performed for all critical processes...
by Dr. Yashashwini Reddy | Sep 13, 2025
1. Area & Environment Filling/packaging areas designed to prevent mix-ups and contamination. Environmental conditions (temperature, humidity, differential pressure) monitored. Cleanliness of the area maintained before, during, and after operation. Adequate...
