required specifications.

Regulatory Affairs Team: Responsible for ensuring that the supplier qualification process complies with applicable regulatory requirements and documenting the process for regulatory submissions.

4. Accountability

The QA Manager is accountable for ensuring that all suppliers are qualified and comply with the necessary regulatory and quality standards. The Procurement Manager is responsible for initiating the qualification process, while the QC Manager ensures that raw materials meet the required specifications after they are received.

5. Procedure

5.1 Supplier Selection

1. The Procurement Team is responsible for identifying potential suppliers for raw materials based on production needs, cost, availability, and historical performance.
2. Potential suppliers should be selected based on their ability to meet quality standards, provide consistent raw materials, and comply with regulatory requirements.
3. The supplier qualification process should be initiated by obtaining relevant information, including:
   • Supplier profile
   • Certifications (e.g., GMP, ISO 9001)
   • Product specifications
   • Quality control measures

5.2 Supplier Audits

1. The QA team will conduct an audit of potential suppliers to assess their facilities, processes, and quality control systems.
2. The audit will include a review of the following:
   • Manufacturing and quality control processes
   • Storage and handling practices for raw materials
   • Compliance with GMP guidelines
   • Documentation practices
   • Health, safety, and environmental policies
3. The results of the audit will be documented in the Supplier Audit Report (Annexure-1), which will be reviewed by the QA Manager for approval.
4. Suppliers who do not meet the necessary standards should be re-evaluated or removed from the approved list.

5.3 Qualification Criteria

1. The supplier must meet the following qualification criteria:
   • Manufacture products in compliance with GMP guidelines
   • Provide raw materials that meet specified quality standards
   • Have a robust quality control system in place
   • Maintain proper documentation for traceability and accountability
   • Be able to provide Certificates of Analysis (CoA) for raw materials upon request
2. The QA team will review the supplier’s documentation, audit results, and quality systems to determine if the supplier meets the qualification criteria.
3. Once the supplier meets all the criteria, they will be approved for use in the cream manufacturing process.

5.4 Ongoing Supplier Monitoring

1. Once a supplier is approved, they will be placed on the Approved Supplier List (ASL), and their performance will be monitored on an ongoing basis.
2. Ongoing monitoring includes:
   • Review of incoming raw materials for compliance with specifications
   • Periodic supplier audits
   • Assessment of supplier performance through complaint records, non-conformances, and delivery timeliness
3. If any issues arise with a supplier, the QA team will initiate an investigation and corrective actions will be taken as necessary.

5.5 Requalification of Suppliers

1. Suppliers must be requalified periodically to ensure they continue to meet the necessary quality and regulatory standards.
2. The frequency of requalification will depend on the risk level associated with the raw materials supplied and the supplier’s performance history.
3. Requalification will include a review of:
   • Supplier audit results
   • Any changes to the manufacturing process or quality control systems
   • Product performance and any customer complaints or recalls
4. If the supplier no longer meets the qualification criteria, they will be removed from the ASL, and an alternative supplier will be identified.

5.6 Documentation and Record-Keeping

1. All supplier qualification activities, including audits, supplier evaluations, and approvals, must be thoroughly documented.
2. Records must include:
   • Supplier audit reports
   • Certificates of Analysis (CoA)
   • Approval and rejection documentation
   • Corrective actions and follow-up records
3. All documentation must be stored securely in a controlled environment to ensure traceability and easy access during audits or inspections.

6. Abbreviations

• GMP: Good Manufacturing Practices
• QA: Quality Assurance
• QC: Quality Control
• SOP: Standard Operating Procedure
• ASL: Approved Supplier List

7. Documents

1. Annexure-1: Supplier Audit Report
2. Annexure-2: Supplier Qualification Form
3. Annexure-3: Approved Supplier List (ASL)

8. References

• Good Manufacturing Practices (GMP) Guidelines – 21 CFR Part 211
• International Conference on Harmonisation (ICH) Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• FDA Guidance for Industry: Supplier Qualification and Auditing

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Supplier Audit Report

Supplier Name	Audit Date	Audit Findings	Corrective Action Required	Responsible Person
XYZ Suppliers	15/01/2026	Inadequate documentation procedures	Implement new documentation control system	QA Manager

Annexure-2: Supplier Qualification Form

Supplier Name	Location	Product Categories	Certifications	Approval Status
ABC Raw Materials	India	Excipient, API	GMP, ISO 9001	Approved

Annexure-3: Approved Supplier List (ASL)

Supplier Name	Product	Approval Status	Last Audit Date
XYZ Raw Materials	Excipient	Approved	15/01/2026

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/03/2024	1.0	Initial Version	New SOP Creation	QA Head
01/03/2025	2.0	Format Revision and Updates	Standardization of Document	QA Head