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Webinar: Next Gen QMS: Quality, Risk & Compliance Unified Through AI

In-Process Control (IPC)

Definition

In-process control refers to checks and tests performed during production,  rather than only at the end of the process. This is done to monitor whether the process is proceeding within its defined parameters. IPCs are typically tied to Critical Process Parameters and Critical Quality Attributes, allowing issues to be caught and addressed in real time.

Benefits

Capturing IPC results directly within the EBR, with automated pass/fail evaluation against predefined limits, allows deviations to be identified and addressed while a batch is still in progress, rather than discovering an issue only after the batch is complete.

Use Case

During tablet compression, an operator performs periodic weight checks as an in-process control. The EBR system requires each result to be entered and automatically compares it against the validated weight range, flagging any result outside tolerance before compression continues.

Frequently Asked Questions (FAQ)

  • IPCs are performed during production to monitor the process as it happens, while release testing is performed on the completed batch to make the final quality determination before release.

  • Yes. IPC results are a standard component of the batch production record and are reviewed as part of the overall batch release decision.

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