SOP: Batch Disposition (Release, Reject, and Quarantine)

This is a ready-to-use SOP for the disposition of a manufactured batch. Replace every <<FILL: ...>> placeholder with your own specifics, set your document numbers and dates, and route it through your normal document control, review, and approval. A worked filled specimen follows the template so you can see how a completed disposition record reads. Verify each cited regulation against the current source before you rely on it. This is general guidance to adapt to your own quality system, not legal or regulatory advice.

Document control header

1. Purpose

This procedure defines how <<FILL: COMPANY NAME>> makes and records the quality decision on the fate of a manufactured batch of drug substance, drug product, or investigational product: release for its intended use, reject, or hold in quarantine while open questions are resolved. The objective is a documented, traceable, independent decision that confirms each batch conforms to its specifications and to the registered process before it is used or distributed.

2. Scope

This procedure applies to every batch of <<FILL: product categories, e.g. drug substance, sterile drug product, cell therapy product>> produced or received at the sites in the header, including commercial and investigational product. It covers standard release, release with an open deviation, and, where registered, parametric and real-time release testing. It does not define the line-by-line batch record review method (see <<FILL: SOP-ID for batch record review>>), the deviation process (see <<FILL: SOP-ID for deviations>>), or the out-of-specification investigation process (see <<FILL: SOP-ID for OOS>>); this procedure consumes their outputs.

3. Responsibilities

4. Definitions

• Quarantine: the default holding state of any newly produced or received material, segregated and not usable until a positive disposition is recorded. Quarantine is the absence of a disposition, not a disposition.
• Release: the signed decision that a batch conforms to all requirements and is cleared for its intended use (distribution, or transfer to the next process step).
• Reject: the signed decision that a batch does not conform and cannot be used as is; it triggers root-cause work and controlled destruction or, only under a pre-approved pathway, reprocessing.
• Disposition package: the assembled set of records and confirmations on which the decision rests (section 5.1).
• Batch-impact assessment: a documented, signed conclusion, on evidence, that a specific quality event does or does not adversely affect the quality, safety, identity, strength, purity, or efficacy of the batch under review.
• Parametric release: release of a terminally sterilized product on validated sterilization parameters and supporting data in place of the finished-product sterility test, only where registered.

5. Procedure

5.1 Assemble the disposition package

Confirm the package is complete before any decision. At minimum it contains:

1. Executed batch production and packaging records, including in-process control results, line clearance, yield reconciliation, and all signatures and verifications.
2. Confirmation that every component, active ingredient, excipient, primary packaging, and printed component was released and within retest or expiry at time of use.
3. Finished-product release test results against the current approved specification, and the finished-batch certificate of analysis.
4. Confirmation that every OOS and OOT result was investigated and closed.
5. The list of every deviation, discrepancy, and change control linked to the batch, each closed or carrying a signed batch-impact assessment.
6. Equipment qualification, calibration, and cleaning status for the equipment used, and environmental and utility data for the relevant manufacturing windows.
7. Confirmation that the batch conforms to the registered or authorised process and specifications (or the IND, IMPD, and clinical protocol for investigational product).

5.2 Review the batch record

Confirm the executed batch record review (per <<FILL: SOP-ID for batch record review>>) is complete: every step performed in sequence, every entry contemporaneous and complete, all in-process controls within limits, yields reconciled, and no unexplained gap.

5.3 Reconcile testing against specification

Confirm every required release test was performed on the correct sample, by a qualified laboratory, against the current approved specification and method, and that all results pass. Confirm any OOS or OOT was closed by a scientifically sound investigation, not retested into compliance. Verify the conclusion, not only the final number.

5.4 Resolve quality events and assess open deviations

For each linked deviation, discrepancy, and change:

1. Confirm it is closed, or open with a batch-impact assessment.
2. Where open, confirm the batch-impact assessment concludes, on evidence, that the event does not adversely affect this batch. The full root-cause investigation and CAPA may remain open provided the batch-impact conclusion does not depend on the missing root cause.
3. Do not proceed to release if any linked event lacks a batch-impact conclusion.

5.5 Confirm the manufacturing environment and regulatory conformance

Confirm equipment was qualified and within calibration, cleaning status was current, no facility-level event touches the batch, and the batch was made and tested per the registered or authorised process. For a change made under change control, confirm it was approved and, where required, notified to or approved by the regulator before commercial use of the changed process.

5.6 Make and record the disposition decision

With the package complete and every prior step satisfied, the disposition authority (or QP for EU market certification) makes and signs the decision on the disposition record (section 8). The record states the outcome, the date, the identity of the decision maker, and references the exact package reviewed. Use an electronic signature meeting <<FILL: SOP-ID for electronic signatures>> where the decision is captured in a validated system.

5.7 Change the system status

Only after the signed decision does inventory status change from quarantine to released or rejected. The status change is tied to the disposition record. The person who manufactured or tested the batch does not perform the status change (segregation of duties).

5.8 Handle a reject

Record the rejection with its basis, route to root-cause investigation and CAPA per <<FILL: SOP-ID>>, apply financial and destruction controls, and evaluate any reporting obligation. Do not reprocess or rework a reject except under a pre-approved, justified pathway supportable against the marketing authorisation.

5.9 Conditional, parametric, and short-shelf-life release

• Release for further processing: a batch may move to a defined internal next step while one non-critical late result is pending, only under <<FILL: SOP-ID or annex>> that names which steps may proceed and what happens if the pending result fails. This is internal and reversible; nothing reaches a patient.
• Parametric release: apply only to a validated terminally sterilized product where the marketing authorisation permits it, on monitored critical parameters, bioburden control, and container-closure integrity data. Any out-of-range parameter reverts the batch to standard disposition and forfeits parametric release for that lot.
• Short-shelf-life product (for example some cell and gene therapies): release before the final sterility result only under the risk-managed pathway registered in the authorisation or protocol, using rapid microbiological methods, with the treating physician informed and a defined contingency if the result later fails.

6. Acceptance criteria

A disposition is acceptable when all of the following are true:

• The decision is documented, signed, and dated by an authorized person, and is traceable to the exact package reviewed.
• Every release test passed against the current approved specification, and every OOS and OOT is closed with a valid investigation.
• Every linked deviation and change is closed or carries a signed batch-impact assessment concluding acceptability on evidence.
• The batch conforms to the registered or authorised process, not only to internal specifications.
• The system status change followed the signed decision, with segregation of duties enforced.
• An independent reviewer who was not present can follow the record and reach the same conclusion.
• The disposition occurred within the timeframe this procedure commits to, with no silent aging in quarantine.

7. References

21 CFR 211.22 (responsibilities of the quality control unit). 21 CFR 211.165 (testing and release for distribution). 21 CFR 211.192 (production record review and investigation of discrepancies).

Describe rather than reproduce the copyrighted or third-party sources: EudraLex Volume 4 Part I Chapter 1 (Pharmaceutical Quality System) and Chapter 6 (Quality Control); EU GMP Annex 16 (Certification by a Qualified Person and Batch Release); EU GMP Annex 17 (Real Time Release Testing and Parametric Release); ICH Q7 sections 2 and 6 for active pharmaceutical ingredients; ICH Q9 (Quality Risk Management) and Q10 (Pharmaceutical Quality System). Confirm the current version and clause numbers of each reference before issue.

8. Record generated: batch disposition record

9. Revision history

10. Approvals

Filled specimen

The following shows the disposition record completed for an illustrative sterile drug product batch released with one open deviation. The company, batch, and numbers are illustrative; replace them with your own.

In this example the deviation’s batch impact was assessed and signed before release (the alarm occurred pre-fill with no product exposed and Grade A counts in limits), while the root-cause investigation stayed open afterward. That split, impact closed before release and investigation continued after, is exactly what a QP or disposition authority is expected to demonstrate.

Common inspection findings this SOP prevents

• A batch released while a linked deviation’s impact on it was never assessed, or while an OOS was open.
• Retesting after an OOS until a passing result appears, then releasing, with no valid basis to invalidate the original.
• Batch record review that is a signature with no evidence the record was actually examined.
• Inventory flipped to released before or without the signed decision, or by the person who made the batch.
• Parametric release claimed for an aseptically processed product, or where it was never registered.
• Batches aging in quarantine for long periods because investigations slipped.

How to adapt this SOP

1. Set your document number, owner, and effective date in the header.
2. Point the cross-references in sections 2, 5.2, 5.4, 5.6, and 5.8 to your real batch record review, deviation, OOS, electronic signature, and CAPA procedures.
3. Decide which release types in section 5.9 apply to your products and delete the rest, or state they are not used.
4. Set your committed disposition timeframe and your quarantine-aging escalation trigger.
5. Confirm every regulation in section 7 against the current published version before issue.