Change control is one of the most critical pillars of pharmaceutical quality systems. Whether the change involves equipment, raw materials, documentation, processes, utilities, or computerised systems, every modification must be evaluated, justified, and implemented in a controlled manner. For quality teams and students pursuing the Quality Assurance and Quality Control Diploma, mastering this process is essential for ensuring compliance, product integrity, and patient safety. This step-by-step guide breaks down the core components of a compliant and effective change control workflow used throughout the pharmaceutical industry. Step 1: Initiate the Change A change begins with a clear, well-documented request. This includes.. READ MORE »
