As Quality Assurance (QA) professionals, auditors, and regulatory experts, we know deviations happen.
The critical question isn't if an OOS or deviation will occur, but how we manage the non-conforming product—specifically, whether we can engage in Rework or Reprocessing.
Navigating the difference and the regulatory allowance is paramount for maintaining product quality and compliance integrity.
Misstep here is a major audit risk!
When it is Allowed?
Rework and Reprocessing are permissible only when all of the following criteria are met:
Quality Unit (QU) Approval:
Every single instance must be reviewed, justified, and approved by the Quality Unit.
Risk Assessment:
A thorough Quality Risk Management (QRM) assessment (e.g., using FMEA) must be conducted to evaluate the potential impact on the product's quality, safety, efficacy, and any potential for new impurities or degradation products.
Validation:
- Reprocessing: The procedure is generally expected to be pre-validated as a standard recovery step.
- Rework: The new procedure must be fully validated to demonstrate that the final product will consistently meet all specifications and characteristics.
Documentation:
Complete and detailed records must be maintained, including the deviation, root cause analysis, risk assessment, rework/reprocessing protocol, execution records, retesting results, and final disposition.
Final Testing:
The finished reworked or reprocessed batch must meet all original specifications, including stability characteristics (often requiring additional stability testing).
Takeaway for Professionals:
- Remember, Reprocessing is a controlled repetition, while Rework is a controlled invention.
- The moment you introduce a non-standard step, the regulatory bar for justification, validation, and approval goes significantly higher.
- Always default to rejection unless a bulletproof case, supported by robust data and validation, can be made.
- Process Validation in Pharmaceutical Industry
- Various Statistical Methods in Pharma
- Reasons of Pharmaceutical Batch Rejection
