by Naveen kumar | Nov 1, 2024
Understanding Why-Why Analysis in Pharmaceuticals: Uncovering the Root of Quality Issues The Why-Why analysis, or “5 Whys,” is a structured root cause analysis method widely used in the pharmaceutical industry to identify and resolve issues at their...
by Naveen kumar | Oct 22, 2024
Quality by Design (QbD) in Pharmaceuticals: Enhancing Drug Development and Manufacturing In the pharmaceutical industry, ensuring product quality is crucial to patient safety and regulatory compliance. Quality by Design (QbD) is a systematic approach to drug...
by Naveen kumar | Oct 18, 2024
Role of the Technology Transfer Department in the Pharmaceutical Industry The Technology Transfer (TT) department is essential in moving pharmaceutical products from development to full-scale manufacturing. Their primary role is to ensure a seamless transfer of...
by Naveen kumar | Oct 1, 2024
Change Control in the Pharmaceutical Industry Change control is a critical process in the pharmaceutical industry, ensuring that any modifications to manufacturing processes, equipment, materials, or documentation are thoroughly evaluated, documented, and approved...
by Naveen kumar | Aug 13, 2024
“Understanding Master Copy, Control Copy, and Obsolete Copy in the Pharmaceutical Industry” In the Pharmaceutical industry document issue is very important and every document is traceable and accountable in the form of master copy, control copy, and...