by Dr. Yashashwini Reddy | Aug 18, 2025
✅ 30 Common Ways to Avoid the Most Frequent GMP Errors Follow approved SOPs strictly. Ensure proper documentation – never backdate or predate entries. Maintain good record-keeping practices (ALCOA+ principles). Always perform line clearance before starting new...
by Dr. Yashashwini Reddy | Aug 18, 2025
Types of Purified Water Systems in Pharmaceuticals Pharmaceutical industries require high-quality water for manufacturing, cleaning, and formulation. Different water systems are designed to meet specific pharmacopeial standards (USP, EP, IP, JP) depending on their...
by Dr. Yashashwini Reddy | Aug 18, 2025
Top 5 Tips for a Successful FDA Inspection: ✅ Top 5 Tips Be Inspection-Ready Always – Maintain compliance at all times, not just when expecting an inspection. Ensure documentation, training records, SOPs, and facilities are always up-to-date. Ensure Documentation...
by Dr. Yashashwini Reddy | Aug 18, 2025
📌 Temperature and Humidity Validation/Mapping in Storage Area Overview:Temperature and humidity mapping is a critical activity in pharmaceutical warehouses, cold rooms, and storage areas to ensure that medicinal products are stored under controlled conditions as per...
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...
