by Dr. Yashashwini Reddy | Oct 8, 2025
🧭 Quality Guidelines – Overview Quality Guidelines are internationally harmonized standards developed mainly by the International Council for Harmonisation (ICH) and other regulatory authorities (like FDA, EMA, WHO, CDSCO).They help ensure that pharmaceutical products...
by Dr. Yashashwini Reddy | Sep 29, 2025
Formats of Pharmaceutical Audits On-Site Audit (Physical Audit) Conducted at the manufacturing site, laboratory, warehouse, or supplier facility. Provides direct observation of processes, equipment, and personnel. Most common format for GMP compliance checks. Remote...
by Dr. Yashashwini Reddy | Sep 29, 2025
Advantages of Pharmaceutical Quality Audits Regulatory Compliance – Ensures adherence to GMP, FDA, EMA, WHO, and other regulatory requirements. Risk Identification – Detects potential risks, deviations, and non-compliance before they become critical issues. Continuous...
by Dr. Yashashwini Reddy | Sep 29, 2025
Aspect Audit Inspection Definition A systematic, independent review to assess compliance with internal or external standards (e.g., GMP). A formal review by a regulatory authority (e.g., FDA, EMA) to ensure compliance with laws and regulations. Conducted By Internal...
by Dr. Yashashwini Reddy | Sep 26, 2025
📌 Case Study: Sun Pharma / Caraco (US) – Recalls due to Contamination and CGMP Non-Compliance Background Caraco Pharmaceutical Laboratories, a US-based generic manufacturer and subsidiary of Sun Pharma, came under FDA scrutiny due to multiple quality issues. As one of...
