Standard Operating Procedure for Control of Non-Conforming Materials
1) Purpose
The purpose of this Standard Operating Procedure (SOP) is to define procedures for identifying, documenting, evaluating, and controlling non-conforming materials within the pharmaceutical manufacturing facility to prevent unintended use or distribution.
2) Scope
This SOP applies to all personnel involved in the identification, handling, and disposition of non-conforming materials, including Quality Assurance (QA), Quality Control (QC), and Production personnel. It covers procedures for non-conformance reporting, investigation, and corrective actions.
3) Responsibilities
– Quality Assurance (QA) Department: Oversees the implementation of the SOP and ensures compliance with regulatory requirements.
– Quality Control (QC) Department: Identifies and documents non-conforming materials during testing or inspection activities.
– Production Department: Supports investigations and implements corrective actions for non-conforming materials.
4) Procedure
4.1 Identification of Non-Conforming Materials
4.1.1 Establish criteria and thresholds for identifying non-conforming materials based on specifications and acceptance criteria.
4.1.2 Promptly segregate and label non-conforming materials to prevent unintended use or distribution.
4.2 Non-Conformance Report (NCR)
4.2.1 Initiate an NCR for each identified non-conformance, documenting details such as nature of non-conformance, batch/lot number, and reason for non-conformance.
4.2.2 Assign priority levels to NCRs based on risk assessment and potential impact on product quality.
4.3 Evaluation
4.3.1 Investigate root causes of non-conformance using appropriate tools and methodologies (e.g., root cause analysis, fishbone diagram).
4.3.2 Determine the extent of the non-conformance and its impact on affected materials and batches.
4.4 Corrective and Preventive Actions (CAPA)
4.4.1 Develop and implement corrective actions to address identified root causes and prevent recurrence of non-conformance.
4.4.2 Monitor the effectiveness of corrective actions through verification and validation activities.
4.5 Material Disposition
4.5.1 Determine appropriate disposition of non-conforming materials based on evaluation results (e.g., rework, retest, scrap).
4.5.2 Obtain approvals from QA for material disposition decisions and ensure proper documentation.
4.6 Documentation
4.6.1 Maintain comprehensive records of all non-conformance activities, including NCRs, investigations, and CAPA implementation.
4.6.2 Ensure that all records are reviewed and approved by the QA department.
4.7 Reporting
4.7.1 Prepare reports summarizing non-conformance trends, investigation findings, and effectiveness of corrective actions.
4.7.2 Submit reports to the QA department for review, approval, and archiving.
5) Abbreviations, if any
– QA: Quality Assurance
– QC: Quality Control
– SOP: Standard Operating Procedure
– NCR: Non-Conformance Report
– CAPA: Corrective and Preventive Actions
6) Documents, if any
– Non-Conformance Reports (NCRs)
– Corrective Action Plans (CAPs)
– Effectiveness Monitoring Records
7) Reference, if any
– FDA Guidance for Industry: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
– ICH Q10 Pharmaceutical Quality System
8) SOP Version
Version 1.0