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SOP for Approval or Rejection of Packaging Materials

Last reviewed 27 Oct 2026 · 3 min read

Contents
  1. Objective
  2. Scope
  3. Responsibilities
  4. Procedure
  5. 1. Receive and identify the shipment
  6. 2. Sample and examine or test
  7. 3. Record the quality decision
  8. 4. Identify and control status
  9. 5. Retain records
  10. Related procedures
  11. References

In short: This example SOP describes how a site can receive, examine, test and document packaging materials before use. Apply the current approved specifications and sampling plan, record the quality decision, and prevent rejected or unreleased materials from entering production.

Objective

To describe an example process for evaluating pharmaceutical packaging materials and documenting their approval or rejection.

Scope

This example applies to packaging materials received for use in pharmaceutical manufacturing, such as containers, closures, printed components and other packaging items. Adapt the steps, responsibilities and records to the site’s approved quality system and the applicable market requirements.

Responsibilities

Example in-house criterion: Quality Control performs sampling and testing assigned by approved specifications; the responsible Quality unit reviews the results and authorises material status; warehouse personnel maintain the required identification and segregation. Define the actual role assignments in the site’s written procedures.

Procedure

1. Receive and identify the shipment

Record the supplier, material name or code, supplier lot or batch number, quantity and receipt date. Check the shipment and containers for visible damage or conditions that could affect the material. Identify the material and keep it in an unreleased status until the required examination or testing and disposition are complete.

2. Sample and examine or test

Written procedures should cover receipt, identification, storage, handling, sampling, examination or testing of packaging and labeling materials. Under 21 CFR 211.122(a) (eCFR current to 23 October 2026), these materials are representatively sampled and examined or tested on receipt and before use. Follow the site’s approved sampling procedure, test method and specification; do not apply an assumed sample size or acceptance limit.

For printed materials, compare the received item with the currently approved artwork or specimen when required by its specification. Record the inspection or test results and any discrepancy.

3. Record the quality decision

Materials that meet the appropriate written specifications may be approved and released for use. Materials that do not meet those specifications must be rejected to prevent use in an unsuitable operation. Record receipt, examination or testing, and acceptance or rejection for each shipment, as required by 21 CFR 211.122(b)–(c) (eCFR current to 23 October 2026).

Document the decision, date, supporting results and authorised reviewer in the site’s controlled record. If results are unclear or a discrepancy is found, hold the material and follow the applicable investigation and escalation procedure before deciding its status.

4. Identify and control status

Example in-house criterion: Use a controlled status label or electronic inventory status to distinguish material awaiting disposition from released and rejected material. Keep rejected material segregated and prevent its issue to production. Handle obsolete or outdated printed material under the site’s controlled destruction procedure.

If a problem is discovered after any material has been issued or used, notify the responsible Quality unit promptly and assess affected operations and product batches under the applicable quality procedures.

5. Retain records

Keep packaging-material receipt, examination or testing, and disposition records for at least 1 year after the expiry date of each respective product batch that uses the material, and longer when local law or the marketing authorisation requires. If one packaging-material lot is used for several batches, retain the records through at least 1 year after the latest applicable batch expiry. For U.S. requirements, 21 CFR 211.180(b) (eCFR current to 23 October 2026) addresses retention of records for components, containers, closures and labeling.

See also sampling of packaging materials, dispensing packaging materials, and label control.

References

  • U.S. Food and Drug Administration. Current Good Manufacturing Practice for Finished Pharmaceuticals, 21 CFR 211.122, eCFR current as of 23 October 2026. Official eCFR text.
  • U.S. Food and Drug Administration. Current Good Manufacturing Practice for Finished Pharmaceuticals, 21 CFR 211.180(b), eCFR current as of 23 October 2026. Official eCFR text.

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