by Dr. Yashashwini Reddy | Oct 8, 2025
🧪 ICH Q2: Analytical Validation 🔹 Full Title: ICH Q2(R2) – Validation of Analytical Procedures 🔹 Objective: To provide guidance on the validation of analytical methods used to test drug substances and products — ensuring that the methods are accurate, reliable, and...
by Dr. Yashashwini Reddy | Sep 8, 2025
A Brief Description of the Entire Audit Process in Pharmaceuticals Audits in the pharmaceutical industry are essential for ensuring compliance with cGMP, regulatory requirements, and internal quality standards. They help identify risks, gaps, and opportunities for...
by Dr. Yashashwini Reddy | Sep 8, 2025
Trends in GMP Violations in Pharmaceuticals Good Manufacturing Practice (GMP) violations remain one of the leading causes of FDA 483s, Warning Letters, and drug recalls. Recent inspection trends show recurring compliance gaps across global pharma companies: 1. Data...
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 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...
