Standard Operating Procedure for Supplier Qualification for Raw Materials in Aerosol Production

1) Purpose

The purpose of this SOP is to establish procedures for the qualification and approval of suppliers providing raw materials used in aerosol production. Supplier qualification ensures that raw materials meet specified quality standards, contributing to the production of safe and effective aerosol products.

2) Scope

This SOP applies to all suppliers of raw materials used in aerosol production at [Company Name], including but not limited to active pharmaceutical ingredients (APIs), excipients, propellants, and packaging materials.

3) Responsibilities

Procurement Manager: Oversee supplier qualification processes and maintain supplier records.
Quality Assurance (QA) Manager: Approve suppliers based on qualification criteria and ensure compliance with quality standards.
Regulatory Affairs: Provide guidance on regulatory requirements related to supplier qualification.
All Personnel: Report any issues related to raw material quality or supplier performance.

4) Procedure

4.1 Supplier Selection:
4.1.1 Identify potential suppliers based on product requirements and specifications.
4.1.2 Evaluate suppliers for capabilities, reliability, and compliance with regulatory standards.
4.1.3 Maintain an approved supplier list (ASL) based on qualification outcomes.

4.2 Initial Supplier Assessment:
4.2.1 Request and review supplier documentation, including quality agreements, certificates of analysis (CoA), and manufacturing licenses.
4.2.2 Conduct on-site audits or assessments, if necessary, to verify supplier facilities and processes.
4.2.3 Evaluate supplier performance history and feedback from other customers, if available.

4.3 Qualification Criteria:
4.3.1 Define qualification criteria for raw material suppliers, including quality standards, regulatory compliance, and supply chain reliability.
4.3.2 Establish acceptance criteria for raw materials based on quality attributes, such as purity, potency, and stability.
4.3.3 Ensure that suppliers meet specific requirements for documentation and traceability of raw materials.

4.4 Approval and Monitoring:
4.4.1 Approve suppliers who meet qualification criteria and demonstrate capability to consistently supply high-quality raw materials.
4.4.2 Monitor supplier performance through periodic evaluations, audits, and review of CoAs.
4.4.3 Update the ASL as necessary based on supplier performance and changes in qualification status.

4.5 Supplier Relationship Management:
4.5.1 Establish and maintain effective communication channels with approved suppliers.
4.5.2 Address any quality issues or deviations promptly through established corrective and preventive actions (CAPA).
4.5.3 Collaborate with suppliers on continuous improvement initiatives to enhance raw material quality and supply chain efficiency.

4.6 Documentation and Record Keeping:
4.6.1 Maintain comprehensive records of supplier qualification activities, including assessments, audits, and approvals.
4.6.2 Archive supplier documentation and qualification records in a secure location for easy access and regulatory inspections.
4.6.3 Retain records of supplier communications and CAPA actions for traceability and compliance purposes.

5) Abbreviations, if any

API: Active Pharmaceutical Ingredient
CoA: Certificate of Analysis
ASL: Approved Supplier List
QA: Quality Assurance
SOP: Standard Operating Procedure

6) Documents, if any

Supplier Qualification Checklist
Supplier Audit Reports
Approved Supplier List (ASL)
Quality Agreements

7) Reference, if any

GMP Guidelines
ICH Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients
FDA Guidance for Industry: Supplier Qualification and Raw Material Verification

8) SOP Version

Version 1.0