Supplier Deviation Management – Standard Operating Procedure
1) Purpose
To establish guidelines for managing deviations related to materials, components, or services supplied by external suppliers to ensure product quality, safety, and compliance within the pharmaceutical manufacturing department.
2) Scope
This SOP applies to all supplier-related deviations identified during receipt, inspection, testing, or use of materials, components, or services in pharmaceutical manufacturing.
3) Responsibilities
Quality Assurance Team: Responsible for investigating and managing supplier deviations.
Procurement Team: Responsible for communicating with suppliers and implementing corrective actions.
4) Procedure
4.1) Deviation Identification:
4.1.1) Identify and document deviations related to supplier materials, components, or services.
4.1.2) Classify deviations based on severity, impact on product quality, and regulatory implications.
4.2) Supplier Notification:
4.2.1) Notify the supplier promptly upon identification of a deviation.
4.2.2) Provide detailed information about the deviation and request a supplier investigation report.
4.3) Supplier Investigation:
4.3.1) Review the supplier investigation report to understand root causes and corrective actions proposed.
4.3.2) Assess the adequacy of the supplier’s investigation and proposed corrective actions.
4.4) Risk Assessment:
4.4.1) Conduct a risk assessment to evaluate the impact of the supplier deviation on
4.4.2) Determine if the affected materials or components can be used, reworked, or need to be quarantined or rejected.
4.5) Corrective and Preventive Actions (CAPA):
4.5.1) Implement corrective actions to address immediate concerns and prevent recurrence.
4.5.2) Communicate CAPA requirements to the supplier and verify implementation effectiveness.
4.6) Documentation and Reporting:
4.6.1) Document all supplier deviation investigations, decisions, and actions taken.
4.6.2) Report significant deviations to management and regulatory authorities as required.
5) Abbreviations, if any
CAPA – Corrective and Preventive Actions
6) Documents, if any
- Supplier Deviation Report Forms
- Supplier Investigation Reports
- Risk Assessment Templates
- Communication Logs with Suppliers
7) Reference, if any
Regulatory Guidelines: FDA CFR Part 211.84, ICH Q10
Industry Standards: ISO 13485:2016
8) SOP Version
Version 1.0