Change Control within regulated sectors like pharmaceutical manufacturing is a critical, systematic procedure for overseeing modifications to documents, systems, or processes. This process encompasses the assessment of proposed changes to gauge their impact on product quality, safety, and regulatory adherence, ensuring changes undergo proper review, validation, and documentation. It’s designed to manage alterations in a structured way to mitigate risks and uphold quality and compliance, highlighting the importance of meticulous evaluation, approval, and implementation practices to maintain product integrity and effectiveness.
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