API Manufacturing: SOP for Reprocessing and Rework Authorization – V 2.0

Posted on By

API Manufacturing: SOP for Reprocessing and Rework Authorization – V 2.0

Standard Operating Procedure for Reprocessing and Rework Authorization in API Manufacturing

Department API Manufacturing
SOP No. SOP/API/170/2025
Supersedes SOP/API/170/2022
Page No. Page 1 of 14
Issue Date 14/04/2025
Effective Date 16/04/2025
Review Date 14/04/2026

1. Purpose

To define the procedure for evaluating, authorizing, executing, and documenting reprocessing or rework of any Active Pharmaceutical Ingredient (API) batch that does not meet predetermined specifications and ensure it is conducted in accordance with current Good Manufacturing Practices (cGMP) and regulatory guidelines.

2. Scope

This SOP applies to all API batches manufactured at the facility that require reprocessing or rework during any phase of

manufacturing, including reaction, filtration, drying, or packaging stages due to quality issues or process deviations.

3. Responsibilities

  • Production: Initiates reprocessing/rework request and carries out approved procedure.
  • QA: Reviews, evaluates, and approves reprocessing/rework protocol; monitors execution.
  • QC: Performs sampling and testing before and after reprocessing/rework.
  • Regulatory Affairs: Informs regulatory bodies if required based on the market and regulatory expectations.
  • Site Head: Grants final approval for reprocessing or rework proposals involving critical changes.
See also  API Manufacturing: SOP for Batch Release Authorization by QA - V 2.0

4. Accountability

The QA Head is accountable for ensuring that reprocessing and rework actions are compliant, risk-evaluated, and properly documented.

5. Procedure

5.1 Definitions

  • Reprocessing: Repeating a step in the manufacturing process that is part of the approved batch manufacturing record (BMR) due to batch failure or deviation.
  • Rework: Subjecting an API batch to one or more processing steps not part of the original manufacturing process to correct a specific failure.

5.2 Identification of Batch for Reprocessing or Rework

  1. If an intermediate or final API batch fails to meet specifications, is out-of-trend (OOT), or shows visual defects, it is quarantined.
  2. Production or QA shall initiate a Reprocessing/Rework Proposal Form (Annexure-1).
  3. The batch shall not be reprocessed/reworked unless formal approval is granted by QA.

5.3 Evaluation and Proposal Preparation

  1. The proposal shall include:
    • Batch number, stage of failure, and reason for deviation
    • Investigation summary and root cause
    • Justification for reprocessing/rework
    • Detailed procedure with parameters
    • Impact assessment on product quality and stability
  2. The proposal must be signed by Production, QC, QA, and approved by the Site Head for critical operations.
See also  API Manufacturing: SOP for Conductivity Measurement in Process Solutions - V 2.0

5.4 Execution of Reprocessing/Rework

  1. Reprocessing or rework shall be executed as per the Approved Protocol (Annexure-2).
  2. All actions must be recorded in the Batch Manufacturing Record Supplement and cross-referenced.
  3. Equipment used must be cleaned and cleared by QA before use.

5.5 Sampling and Testing

  1. QC shall perform in-process testing as outlined in the protocol.
  2. Final samples post reprocessing/rework must be tested for full specifications.
  3. Stability testing shall be initiated if the product is intended for long-term storage or global markets, depending on regulatory requirements.

5.6 Release and Disposition

  1. If the reprocessed/reworked batch meets all specifications and is found to be equivalent to original quality, QA may approve its release.
  2. In case of failure, the batch may be rejected and disposed of as per waste disposal SOP.

5.7 Documentation

  1. All records shall be archived in the respective batch file.
  2. Reprocessing/rework history shall be trended quarterly (Annexure-3).
  3. Repeat failures in the same process shall trigger process revision or CAPA.

See also  API Manufacturing: SOP for Polymorph Screening Method - V 2.0

6. Abbreviations

  • API: Active Pharmaceutical Ingredient
  • BMR: Batch Manufacturing Record
  • QA: Quality Assurance
  • QC: Quality Control
  • CAPA: Corrective and Preventive Action

7. Documents

  1. Reprocessing/Rework Proposal Form (Annexure-1)
  2. Approved Reprocessing/Rework Protocol (Annexure-2)
  3. Reprocessing/Rework Trending Log (Annexure-3)

8. References

  • ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
  • 21 CFR 211.115 – Reprocessing
  • EU GMP Part II: Reprocessing and Reworking Guidelines

9. SOP Version

Version: 2.0

10. Approval Section

Prepared By Checked By Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Reprocessing/Rework Proposal Form

Batch No. Date Stage of Failure Reason
BA-1025 05/04/2025 Drying Moisture above spec

Annexure-2: Approved Protocol Summary

Activity Details Duration Person Responsible
Repeat drying At 60°C under vacuum 6 hours Rajesh Kumar

Annexure-3: Reprocessing/Rework Trending Log

Month Total Batches Reprocessed Reworked Rejected
March 2025 25 2 1 0

Revision History:

Revision Date Revision No. Details Reason Approved By
01/01/2022 1.0 Initial Issue New SOP QA Head
14/04/2025 2.0 Clarified definitions and introduced trending log Regulatory enhancement QA Head
API Manufacturing V 2.0 Tags:, , , , , , , , , , , , , , , , , , , , , , , ,