CAPA (Corrective and Preventive Action) is not just a documentation exercise—it is a regulatory expectation under Pharmaceutical Quality System (PQS) as per World Health Organization, US Food and Drug Administration, and International Council for Harmonisation. 🧩 1. Define the Problem Read More …
Tag: QA
10 Golden Rules of Good Manufacturing Practice (GMP) Every Pharma Professional Must Know
🔑 1. Follow Written Procedures (SOPs) 📖 Explanation Every activity must be performed according to an approved SOP. SOPs ensure consistency, reproducibility, and compliance. 🧪 Real Example Case: Granulation process in solid dosage section 👉 Audit Finding: Process deviation👉 Impact: Read More …
Dissolution, Disintegration, Hardness & Friability Testers in Pharmaceutical QC
In pharmaceutical quality control (QC), solid oral dosage forms such as tablets and capsules must consistently meet predefined performance and mechanical integrity standards. Four essential instruments—dissolution tester, disintegration tester, hardness tester, and friability tester—play a critical role in ensuring compliance Read More …
HVAC Validation in the Pharmaceutical Industry
Introduction to HVAC Validation HVAC (Heating, Ventilation, and Air Conditioning) validation in the pharmaceutical industry is a systematic, documented approach to ensure that air handling systems consistently maintain the required environmental conditions for manufacturing. These conditions include temperature, relative humidity, Read More …
💻 Computerized System Validation (CSV) in Pharmaceutical Industry
Ensuring Data Integrity, Compliance & Patient Safety 🔍 Introduction to CSV in Pharma In today’s pharmaceutical manufacturing environment, computerized systems are deeply integrated into every stage of the product lifecycle—from research and development to manufacturing, quality control, and distribution. Computerized Read More …