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
In the pharmaceutical industry, quality audits are critical for ensuring compliance with Good Manufacturing Practices (GMP), regulatory guidelines, and internal quality standards. The main types of audits include: Types of Quality Audits in Pharma Internal Audit...
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 23, 2025
Case Study: Supply Chain Disruption – API Shortage Background A U.S.-based pharmaceutical company manufacturing essential cardiovascular and anti-diabetic medicines faced a sudden API (Active Pharmaceutical Ingredient) shortage in 2024. The primary API supplier was...
by Dr. Yashashwini Reddy | Sep 20, 2025
1. Premises and Equipment Use dedicated and clean facilities for production, storage, and filling of gases. Ensure gas cylinders, pipelines, valves, regulators, and manifolds are properly maintained and validated. Prevent cross-contamination between medical and...
