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
📋 Types of Audits in the Pharmaceutical Industry 1. Internal Audit (Self-Inspection) Purpose: To assess compliance with internal SOPs and GMP requirements. Conducted By: Company’s own QA or compliance team. Frequency: Regularly scheduled (e.g., annually or quarterly)....
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: HeLa Cells & Informed Consent In 1951, Henrietta Lacks, an African-American woman, was treated for cervical cancer at Johns Hopkins Hospital. Without her knowledge or consent, doctors collected her tumor cells, which turned out to be the first human...
by Dr. Yashashwini Reddy | Sep 23, 2025
🧪 Case Study: Cross-Contamination in a Multi-Product Pharmaceutical Facility 📌 Background A European pharmaceutical manufacturer operated a multi-product solid oral dosage plant. During a routine EMA inspection, regulatory authorities found traces of a potent API...
