by Dr. Yashashwini Reddy | Sep 9, 2025
🏭 How FDA Inspections are Conducted in Manufacturing Facilities 1. Pre-Inspection Phase FDA identifies facilities to inspect based on: Risk-based selection (product type, compliance history, criticality, recalls, complaints). New drug approval or pre-approval...
by Dr. Yashashwini Reddy | Sep 9, 2025
🧫 Typical Microbiology Concerns in an FDA Inspection 1. Environmental Monitoring (EM) Deficiencies Inadequate EM program for cleanrooms and controlled areas. Failure to establish alert/action limits based on historical data. Poor trending and lack of investigation of...
by Dr. Yashashwini Reddy | Sep 9, 2025
🧾 Improving Quality Through Supplier Audits in Pharmaceuticals Supplier audits are critical in ensuring that raw materials, APIs, packaging components, and outsourced services meet GMP and regulatory expectations. A strong supplier audit program reduces compliance...
by Dr. Yashashwini Reddy | Sep 9, 2025
🧾 Common FDA 483 Observations Related to Cleaning in Pharmaceuticals 1. Inadequate Cleaning Validation Cleaning validation not performed for all product-contact equipment. Worst-case product selection (hardest to clean, most toxic/potent, least soluble) not justified....
by Dr. Yashashwini Reddy | Sep 8, 2025
Impact of Culture and Behaviors on Data Integrity Compliance in Pharmaceuticals Data integrity is not only about systems and SOPs, but also about people’s mindset, culture, and daily behaviors. Even the best electronic systems and QMS can fail if employees lack the...
