What is change control ? Step by step handling of change control with examples ( Production department)
In pharmaceutical production, change control is a crucial process that ensures any modifications to equipment, processes, or procedures are managed systematically and safely. Here are some examples of how change control is handled in the pharma industry: Equipment Change: When a pharmaceutical company decides to replace or upgrade a critical manufacturing equipment, a formal change control process is initiated. It involves assessing the impact of the change, conducting risk assessments, and ensuring proper validation of the new equipment before implementation. Process Change: If there is a need to modify a manufacturing process, change control is employed to evaluate the potential impact on product quality, safety, and efficacy. This process includes thorough documentation, testing, and validation to ensure the changes do not compromise product quality. Raw Material Change: When there is a need to switch or modify a raw material used in drug manufacturing, change control is applie...