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
📋 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 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...
by Dr. Yashashwini Reddy | Sep 22, 2025
WHO Guidance on Cross-Contamination Definition:Cross-contamination is the unintended presence of one product (or its residues, microbes, cleaning agents, etc.) in another product. Prevention Measures (as per WHO TRS, GMP guidelines): Dedicated facilities or equipment...
by Dr. Yashashwini Reddy | Sep 15, 2025
Guide to Inspections of High Purity Water Systems 1. Introduction High Purity Water (HPW) systems, including Purified Water (PW), Water for Injection (WFI), and Highly Purified Water (HPW), are critical utilities in pharmaceutical manufacturing. Regulatory agencies...
