(Domain Knowledge) Current Good Manufacturing Practices: Part 1
This is a article aimed toward building on knowledge on Current Good Manufacturing Practices (cGMP). This article will answer on: What is cGMP? What are the core principles of cGMP? What are the pillars of cGMP? Deep dive into Management & Personnel pillars. Current Good Manufacturing Practice (cGMP): - is a systemic approach to manufacturing that ensures products—such as pharmaceuticals and medical devices—are consistently produced and controlled according to quality standards. cGMP is about building quality into the process of medicine development because it given finer control. It is needed because, in medicine, a mistake isn't just a financial loss; it is a risk to human life. cGMP provides the "checks and balances" necessary to ensure every pill, vial, or device is safe, pure, and effective. The 15 Core Principles of cGMP To manage the complexity of manufacturing, cGMP is typically broken down into 15 essential practices. These can be grouped into four m...