Quality
Conditional release
Releasing a batch before all tests are complete — only permitted under specific rules (e.g. PET drugs).
Conditional release allows a batch to be released for use before every release test is complete — only when the regulator explicitly permits it (e.g. 21 CFR 212.70(d) for PET drugs due to short half-life). The pending tests must still be performed; if they fail, the batch must be recalled. V5 makes the conditional-release decision an explicit signed event with a recall plan attached.
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