Glossary
Time Limit / Hold Time
Also writtenholding time
Setting the time by which each production phase must be completed and the maximum time materials, in-process product, or bulk may be held before the next step, so that quality is assured.
Details
21 CFR 211.111 requires time limits for the completion of each phase of production where they are necessary to assure product quality, and requires deviations from them to be documented and justified as not compromising quality. WHO TRS 992 Annex 4 describes hold time as the established period for which dispensed materials, intermediates, and bulk awaiting final packaging remain within specification under defined conditions, and requires the limits for each stage to be set by hold time studies in which samples from representative batches are held in the actual or simulated container for the defined period and then tested; for sterile products, EU GMP Annex 1 §8.36 requires the maximum time from the start of preparation to sterilisation to be reflected in the sterilisation validation. If stability testing asks whether the finished product holds up over its shelf life, hold time asks whether in-process material holds up until the next step. Inspections cite time limits never established at all (a standard FDA 483 finding), batch records with no start and finish times for each stage so that compliance cannot be told, and bulk hold periods extended with no supporting data.
Related sections
Related terms
Real inspection findings
Findings from regulators' inspection documents in which this term appears.
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Failure to establish, when appropriate, time limits for the completion of each phase of production to assure the quality of the drug product [21 CFR 211.111].
FDA · FDA Warning Letter · 2021-08-17 -
The master batch production record lacks an established time limits and detailed production instructions to ensure 1he quality of intermediates and AP[s are met for individual processing steps and/or total process.
FDA · FDA 483 · 2025-03-06 -
Time limits are not established for the completion ofeach production phase to assure the quality ofthe drug product.
FDA · FDA 483 · 2026-05-06
Counted as of 2026-09-24 — the search you land on shows today's figures, so it may differ slightly.
Source
21 CFR 211.111 Time limitations on production; WHO TRS 992 Annex 4 General guidance on hold-time studies §4GRM Regulatory Glossary
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