Standard Operating Procedure for Vendor Qualification and Management in Otic Manufacturing Unit

1) Purpose

To establish criteria and procedures for the qualification, selection, evaluation, and ongoing management of vendors supplying materials and services to the Otic manufacturing unit, ensuring compliance with quality standards and regulatory requirements.

2) Scope

This SOP applies to all personnel involved in vendor selection, qualification, evaluation, and management within the Otic manufacturing unit.

3) Responsibilities

Procurement Department: Responsible for initiating and overseeing the vendor qualification process.
Quality Assurance (QA) Department: Responsible for ensuring vendors meet quality and regulatory requirements.
Quality Control (QC) Department: Responsible for sampling and testing materials received from vendors.
Regulatory Affairs Department: Responsible for maintaining documentation related to vendor qualification and audits.

4) Procedure

4.1 Vendor Selection
4.1.1 Identification of Vendor Needs
4.1.1.1 Initiate vendor selection process based on procurement requirements.
4.1.1.2 Define criteria for vendor selection based on product or service specifications.

4.1.2 Vendor Evaluation
4.1.2.1 Assess potential vendors based on capability, quality systems, and regulatory compliance.
4.1.2.2 Conduct initial screening and shortlist qualified vendors for further evaluation.

4.2 Vendor Qualification
4.2.1 Documentation Review
4.2.1.1 Obtain and review vendor documentation, including quality agreements and certifications.
4.2.1.2 Verify compliance with GMP requirements and specific standards relevant to Otic dosage forms.

4.2.2 On-Site Audit
4.2.2.1 Conduct on-site audits of critical vendors to assess facilities, processes, and quality systems.
4.2.2.2 Evaluate audit findings and determine vendor qualification status.

4.3 Vendor Performance Monitoring
4.3.1 Performance Metrics
4.3.1.1 Define key performance indicators (KPIs) for vendor performance evaluation.
4.3.1.2 Monitor vendor performance against agreed-upon KPIs and quality standards.

4.3.2 Continuous Improvement
4.3.2.1 Implement corrective actions and preventive measures based on vendor performance issues.
4.3.2.2 Conduct periodic reviews and reassessments of vendor qualification status.

4.4 Vendor Change Control
4.4.1 Change Notification
4.4.1.1 Notify relevant departments of changes in vendor status, products, or services.
4.4.1.2 Evaluate impact on quality and regulatory compliance before implementing changes.

4.4.2 Requalification
4.4.2.1 Requalify vendors periodically or in response to significant changes.
4.4.2.2 Update vendor qualification documentation accordingly.

5) Abbreviations, if any

SOP: Standard Operating Procedure
GMP: Good Manufacturing Practice
KPI: Key Performance Indicator

6) Documents, if any

Vendor qualification checklist
Quality agreements
Audit reports
Performance evaluation records

7) Reference, if any

GMP guidelines for vendor qualification and management in pharmaceutical manufacturing

8) SOP Version

Version 1.0