by Dr. Yashashwini Reddy | Aug 18, 2025
Possible Causes of OOS Results 1. Laboratory Errors Improper sample preparation or dilution Incorrect weighing or pipetting Instrument malfunction or improper calibration Wrong method execution or deviation from SOP Calculation or transcription errors 2....
by Dr. Yashashwini Reddy | Aug 18, 2025
Gap Analysis for Regulatory Compliance Gap Analysis is a structured approach used in pharmaceutical and life sciences industries to identify the differences (“gaps”) between current practices and regulatory requirements or industry standards (e.g., FDA, EMA, ICH,...
by Dr. Yashashwini Reddy | Aug 18, 2025
Cleaning Validation of Manufacturing Equipment Cleaning validation is a documented process that ensures manufacturing equipment in the pharmaceutical industry is consistently cleaned to predetermined limits, preventing contamination and cross-contamination between...
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
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...
