Manufacturing and quality

Process validation and knowledge transfer

FDA presents validation as a lifecycle: process design, process qualification and continued process verification. A few successful batches do not replace process understanding and monitoring.

Sources and scope checked: 3 October 2026 · Guide version 1

Scope: US guidance; establish product and market requirements before approving a protocol.

View my progress Practise in the lab

Prepare your evidence before a decision

Mark the prompts for which you have organised evidence. Completion tracks preparation; it does not establish product or site compliance.

Collect development knowledge and relevant quality attributes.
Link process parameters to risks and control evidence.
Define sampling and acceptance criteria before execution.
Plan ongoing monitoring of trends and deviations.

You can use and print this checklist without electronic saving.

Ticks are saved only in this browser. No documents or patient data are sent. The download includes prompt status and source links.

Process validation and knowledge transfer

Prepare your evidence before a decision

Continue to practice