SOP for Reprocessing and Reworking
Standard Operating Procedure (SOP)
1. Objective
To establish standardized procedures for reprocessing and reworking pharmaceutical products to ensure that all batches meet predefined specifications and maintain product quality.
2. Scope
This SOP applies to all departments involved in the manufacturing process, including Production, Quality Control (QC), Quality Assurance (QA), Engineering, and Research & Development (R&D). It encompasses failures related to raw materials, equipment, processes, and finished products.
3. Definitions
-
Reprocessing: Subjecting all or part of a batch or lot of an in-process drug, bulk process intermediate, or bulk product of a single batch/lot to a previous step in a validated manufacturing process due to failure to meet predetermined specifications.
-
Reworking: Subjecting an in-process material or drug product that does not conform to standard or specification to one or more processing steps that are different from the manufacturing process described in the application to obtain acceptable quality in-process material or drug product.
4. Responsibilities
-
Production: Initiate reprocessing or reworking requests, conduct investigations, and implement corrective actions.
-
Quality Assurance: Review and approve reprocessing or reworking requests, ensure compliance with SOPs, and monitor the effectiveness of corrective actions.
-
Quality Control: Perform necessary testing and analysis to ensure that reprocessed or reworked products meet quality specifications.
-
Management: Provide oversight and ensure that reprocessing and reworking activities are conducted in compliance with regulatory requirements.
5. Procedure
5.1 Initiation of Reprocessing/Reworking
-
Identification: Detect deviations or non-conformances during manufacturing or post-manufacturing stages.
-
Investigation: Conduct a thorough investigation to determine the root cause of the deviation.
-
Documentation: Complete a deviation report detailing the nature of the issue, affected batch details, and initial observations.
5.2 Risk Assessment
-
Evaluation: Assess the potential impact of reprocessing or reworking on product quality and patient safety.
-
Approval: Obtain approval from the Quality Assurance department before proceeding.
5.3 Implementation
-
Reprocessing: Return the product to a previous validated step in the manufacturing process.
-
Reworking: Apply different processing steps to bring the product into conformance with specifications.
-
Documentation: Maintain detailed records of all actions taken, including batch numbers, equipment used, and personnel involved.
5.4 Testing and Release
-
Analysis: Perform necessary testing to confirm that the reprocessed or reworked product meets all quality specifications.
-
Approval: Obtain approval from Quality Control and Quality Assurance for release.
5.5 Post-Implementation Review
-
Monitoring: Track the performance of reprocessed or reworked products to ensure continued compliance.
-
Reporting: Document the outcomes and any further actions taken.
🎓 Discover one of the best Pharmaceutical Production courses available — click below to explore the course that’s shaping future Production skills.