Glossary
In-Process Control (IPC)
Checks performed during manufacture, with adjustment where necessary, so that an intermediate or API conforms to its specification.
Source · ICH Q7 (2000), §20 Glossary, In-Process Control (or Process Control)
Details
Rather than screening by testing the finished product, this keeps a batch uniform by checking values while manufacture is under way. Because 21 CFR 211.110(a) gives tablet and capsule weight variation, disintegration time, blend uniformity, dissolution, and the clarity and pH of solutions as examples, findings quote that same list. The corpus cites procedures that omitted tablet and capsule checks or had no clarity check for solutions, so also look at whether the in-process limits are consistent with the finished product specification (211.110(b)).
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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Failure to establish and follow written procedures that describe the in-process controls, and tests, or examinations to be conducted on appropriate samples of in-process materials of each batch [21 CFR 211.110(a)].
FDA · FDA Warning Letter · 2024-05-28 -
In-process control procedures are deficient in that your control procedures do not include bioburden testing [21 CFR 211.110(a)(6)].
FDA · FDA Warning Letter · 2024-01-09 -
The in-process control procedures were deficient in that it did not include an examination of tablet and capsule weight variation.
FDA · FDA 483 · 2018-04-11
Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.
Source
ICH Q7 (2000), §20 Glossary, In-Process Control (or Process Control)GRM Regulatory Glossary
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