Standard Operating Procedure for Control of Non-Conforming Materials

1) Purpose

The purpose of this Standard Operating Procedure (SOP) is to establish procedures for identifying, segregating, evaluating, and dispositioning non-conforming materials within the pharmaceutical manufacturing facility to prevent unintended use or distribution.

2) Scope

This SOP applies to all non-conforming materials identified during receipt, production, testing, storage, or distribution processes. It covers procedures for non-conformance assessment, investigation, and corrective actions.

3) Responsibilities

– Quality Assurance (QA) Department: Oversees non-conforming material control procedures and ensures compliance with SOP and regulatory requirements.
– Quality Control (QC) Department: Identifies and assesses non-conforming materials through inspection, testing, or other evaluation methods.
– Production and Warehouse Personnel: Assist in the segregation and disposition of non-conforming materials as per defined procedures.

4) Procedure

4.1 Non-Conformance Identification
4.1.1 Identify and segregate non-conforming materials during receipt, production, testing, or other relevant stages of material handling.
4.1.2 Label non-conforming materials with non-conformance tags or labels to prevent unintended use or distribution.
4.2 Non-Conformance Assessment
4.2.1 Assess non-conforming materials through visual inspection, testing, or other evaluation methods to determine the extent and impact of non-conformance.
4.2.2 Document assessment findings, including non-conformance details, reasons for non-conformance, and initial risk assessment.
4.3 Non-Conformance Investigation
4.3.1 Investigate root causes of non-conformance using appropriate tools and techniques (e.g., root cause analysis, fishbone diagram).
4.3.2 Identify corrective actions and preventive actions (CAPA) to address root causes and prevent recurrence of non-conformances.
4.4 Non-Conformance Disposition
4.4.1 Determine disposition options for non-conforming materials based on risk assessment, regulatory requirements, and product impact (e.g., rework, retest, scrap).
4.4.2 Obtain approvals for disposition decisions from designated personnel (e.g., QA, Production Manager) before implementation.
4.5 Non-Conformance Documentation
4.5.1 Maintain comprehensive records of non-conforming material identification, assessment, investigation, and disposition activities.
4.5.2 Ensure that all records are documented, reviewed, approved, and archived in accordance with SOP requirements.
4.6 Non-Conformance Review and Reporting
4.6.1 Review non-conformance records periodically to identify trends, recurring issues, and opportunities for process improvement.
4.6.2 Prepare summary reports on non-conformance activities, including trends observed, corrective actions implemented, and effectiveness reviews.
4.7 Documentation
4.7.1 Maintain comprehensive records of non-conforming material control procedures, non-conformance assessments, investigations, and dispositions.
4.7.2 Ensure that all records are reviewed, approved, and archived by the QA department in accordance with SOP requirements.
4.8 Reporting
4.8.1 Prepare periodic reports summarizing non-conforming material control activities, including compliance status and any corrective actions taken.
4.8.2 Submit reports to the QA department for review, approval, and archiving.

5) Abbreviations, if any

– QA: Quality Assurance
– SOP: Standard Operating Procedure
– QC: Quality Control
– CAPA: Corrective and Preventive Actions

6) Documents, if any

– Non-Conformance Reports
– CAPA Plans and Reports
– Non-Conformance Trend Analysis Reports

7) Reference, if any

– FDA Guidance for Industry: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production
– ICH Q9 Quality Risk Management

8) SOP Version

Version 1.0