Batch Release: The Decision and Who Owns It

Release is the decision that a batch conforms to its specification and may be distributed, made by a named person and recorded.

Under 21 CFR 211.22 the quality control unit has the authority to approve or reject, and that authority cannot sit with production.

What the decision rests on

• The batch record is complete, with every significant step performed, checked, dated and signed.
• Analytical results meet specification, and any OOS result has a closed investigation with a documented conclusion.
• Deviations are closed, with their product impact assessed.
• In-process controls met their limits.
• The yield is within expected range, or the discrepancy is investigated.
• Labeling and packaging records reconcile.
• The batch was made in a validated process on qualified equipment, by trained people.

An open deviation with unassessed product impact blocks release. So does an unresolved OOS. Releasing over either is the finding that appears in warning letters.

The EU Qualified Person

In the EU a Qualified Person certifies each batch personally, and the certification is a legal act attached to a named individual with defined qualifications and experience.

The QP certifies that the batch was manufactured and tested in accordance with the marketing authorization and GMP. For imported product the QP also confirms testing was performed in the EU or under a mutual recognition agreement.

In the US the quality unit approves as a function. In the EU the QP signs and carries the legal responsibility.

Parametric release

For terminally sterilised products, parametric release replaces sterility testing with the demonstrated sterilisation cycle data. Approval is product-specific and requires a validated cycle with continuous monitoring, and it is a change to the application rather than an internal decision.

Common release failures

Released under time pressure with an open investigation, on the reasoning that the result will probably be fine.

Reconciliation not actually checked. Label accountability is a routine reconciliation and a routine finding.

The releasing person did not see the deviations, because the deviation system and the batch record live in different places and nothing joins them.