In-Process Control
In-Process Control (IPC)
What a definition is not
A definition is SPEQ’s plain-language decode of how a term is used in practice, cited to the documents that define it. It is a practitioner reference, not legal or regulatory advice, it does not replace the definition in the source, and where a regulator’s wording differs the regulator’s wording governs.
Checks, tests, and measurements performed on materials or intermediates during production — such as fill weight, pH, tablet hardness, or blend homogeneity — used to monitor and, where the process design permits, adjust the manufacturing process in real time to ensure the finished product will conform to specification, distinct from final release testing performed after manufacture is complete.
IPCs are chosen because they measure attributes that predict or drive final product quality but can still be corrected or acted on while the batch is in progress, unlike release testing, which only confirms conformance after the fact.
Where an IPC is directly linked to a critical quality attribute through the process design, it may be defined as a critical process parameter with its own control strategy and alarm limits, tighter than the eventual release specification.
IPC results are recorded contemporaneously in the batch record and reviewed as part of batch disposition, and an out-of-limit IPC result — even where the finished product ultimately passes release testing — is typically investigated as a process deviation.
- —Performed during manufacture, distinct from final release testing performed on the completed batch.
- —Selected because the attribute can still be corrected while production is underway.
- —May be tied to a critical process parameter with its own tighter control limits.
- —Out-of-limit IPC results are recorded in the batch record and typically investigated.
21 CFR 211.110; EU GMP Chapter 4; ICH Q10
Frequently asked questions
What does In-Process Control stand for?
In-Process Control stands for In-Process Control (IPC).
What is In-Process Control?
Checks, tests, and measurements performed on materials or intermediates during production — such as fill weight, pH, tablet hardness, or blend homogeneity — used to monitor and, where the process design permits, adjust the manufacturing process in real time to ensure the finished product will conform to specification, distinct from final release testing performed after manufacture is complete.
Which regulations cover In-Process Control?
21 CFR 211.110; EU GMP Chapter 4; ICH Q10