Process Performance Qualification (PPQ) in pharmaceutical manufacturing is the practice of generating documented evidence to demonstrate that a manufacturing process consistently yields products that meet predefined quality specifications and requirements under standard operating conditions. This involves conducting and assessing manufacturing runs on a commercial scale, employing established equipment and processes to validate process capability, reproducibility, and reliability. PPQ encompasses process validation, ongoing process monitoring, and product testing activities, all aimed at confirming the process’s ability to reliably produce pharmaceutical products in alignment with quality standards and regulatory mandates.
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