SOP for Vendor Qualification for Aerosol Components
| Department | Aerosol |
|---|---|
| SOP No. | SOP/Aerosol/163/2025 |
| Supersedes | SOP/Aerosol/163/2022 |
| Page No. | Page 1 of Y |
| Issue Date | 06/02/2025 |
| Effective Date | 16/02/2025 |
| Review Date | 06/02/2028 |
1. Purpose
The purpose of this Standard Operating Procedure (SOP) is to define the process for qualifying vendors supplying aerosol components such as propellants, containers, valves, actuators, and other raw materials. Vendor qualification ensures that suppliers meet quality, regulatory, and business requirements before being approved for procurement.
2. Scope
This SOP applies to all vendors supplying raw materials, packaging materials, and components used in aerosol manufacturing. It includes the selection, evaluation, approval, and periodic re-evaluation of vendors.
3. Responsibilities
- Procurement Team: Responsible for identifying potential vendors, gathering initial information, and coordinating qualification activities.
- Quality Assurance (QA) Team: Responsible for assessing vendor compliance with GMP, regulatory requirements, and internal quality standards.
- Regulatory Affairs Team: Responsible for ensuring vendor compliance with applicable industry regulations.
- Audit Team: Responsible for conducting on-site or remote audits of vendors as part of the qualification process.
- Production Team: Responsible for providing input on vendor performance and suitability for manufacturing operations.
4. Accountability
The Quality Assurance (QA) Manager and Procurement Manager are accountable for ensuring that vendor qualification procedures are followed, and only approved vendors supply aerosol components.
5. Procedure
5.1. Identifying Potential Vendors
- Procurement identifies potential vendors
based on business needs and regulatory requirements.
Initial information is collected, including company profile, certifications, past experience, and product specifications.
A Vendor Pre-Qualification Questionnaire (Annexure-1) is sent to vendors to assess compliance with industry standards.
5.2. Vendor Evaluation Process
- The QA team reviews the completed questionnaire and supporting documents such as:
- ISO and GMP certifications
- Quality control procedures
- Material safety data sheets (MSDS)
- Batch test reports
- Regulatory Affairs verifies that the vendor complies with regulatory requirements for aerosol manufacturing.
- The vendor’s history of supplying materials to other manufacturers is assessed.
5.3. Vendor Audits
- If required, an on-site or virtual audit is conducted by the Audit Team.
- The audit assesses:
- Manufacturing and quality control processes
- Raw material handling and storage
- Compliance with regulatory guidelines
- Documented standard operating procedures (SOPs)
- The Audit Report (Annexure-2) is prepared and reviewed by the QA team.
5.4. Vendor Approval
- Based on the evaluation, a decision is made to:
- Approve the vendor
- Conditionally approve with specific requirements
- Reject the vendor
- An Approved Vendor List (Annexure-3) is maintained and updated regularly.
- All approvals are documented in the Vendor Qualification Report (Annexure-4).
5.5. Periodic Vendor Re-Evaluation
- Approved vendors are reviewed annually or when significant changes occur in:
- Material specifications
- Quality incidents or complaints
- Regulatory requirements
- Re-evaluation findings are recorded in the Vendor Performance Review Log (Annexure-5).
5.6. Vendor Disqualification
- Vendors may be disqualified for:
- Repeated quality issues
- Regulatory non-compliance
- Failure to meet contract obligations
- Disqualification is documented, and alternative vendors are identified.
6. Abbreviations
- GMP: Good Manufacturing Practice
- QA: Quality Assurance
- SOP: Standard Operating Procedure
- MSDS: Material Safety Data Sheet
- ISO: International Organization for Standardization
7. Documents
- Vendor Pre-Qualification Questionnaire (Annexure-1)
- Audit Report (Annexure-2)
- Approved Vendor List (Annexure-3)
- Vendor Qualification Report (Annexure-4)
- Vendor Performance Review Log (Annexure-5)
8. References
- Good Manufacturing Practice (GMP) Guidelines
- ISO 9001 – Quality Management Systems
- FDA Supplier Qualification Requirements
9. SOP Version
Version: 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Vendor Pre-Qualification Questionnaire
| Vendor Name | Material Supplied | Certification | Compliance Status | Remarks |
|---|---|---|---|---|
| XYZ Chemicals | Propellants | ISO 9001 | Compliant | Approved |
Annexure-2: Audit Report
| Vendor Name | Audit Date | Audit Findings | Corrective Actions | Final Status |
|---|---|---|---|---|
| XYZ Chemicals | 06/02/2025 | Compliant | N/A | Approved |
12. Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | V 1.0 | Initial Release | First Issue | Anjali Sharma |
| 01/01/2025 | V 2.0 | Updated qualification process | GMP Compliance | Anjali Sharma |