Standard Operating Procedure for Quality Agreements with Third Parties

1) Purpose

This SOP outlines the procedures for establishing and maintaining quality agreements with third-party suppliers, contractors, and service providers to ensure compliance with quality standards and regulatory requirements.

2) Scope

This SOP applies to all quality agreements established with third-party suppliers, contractors, and service providers involved in activities related to the manufacture, testing, packaging, labeling, storage, and distribution of pharmaceutical products.

3) Responsibilities

The Quality Assurance Manager or designated personnel are responsible for overseeing the establishment and maintenance of quality agreements. Procurement, quality control, regulatory affairs, and other relevant departments are responsible for implementing the terms of the quality agreements.

4) Procedure

4.1 Agreement Initiation

1. Identify the need for a quality agreement based on the nature and criticality of the third-party activities.
2. Initiate discussions with the third party to outline the scope, responsibilities, and expectations.

4.2 Agreement Content

1. Define the roles, responsibilities, and authorities of both parties regarding quality-related activities.
2. Specify quality standards, requirements, and expectations for the products or services provided by the third party.

4.3 Quality Metrics

1. Establish key quality metrics (e.g., batch failure rates, complaint rates, on-time delivery) to measure the performance of the third party.
2. Define acceptable performance levels and expectations for continuous improvement.

4.4 Change Control

1. Implement a change control process to manage any changes to the quality agreement.
2. Define procedures for notifying and obtaining approval from both parties for proposed changes.

4.5 Communication and Reporting

1. Establish communication channels and protocols for ongoing dialogue between the parties regarding quality issues, deviations, and corrective actions.
2. Require regular reporting from the third party on quality-related metrics and performance.

4.6 Compliance and Audits

1. Ensure the third party complies with all applicable regulatory requirements and company policies.
2. Conduct periodic audits or assessments of the third party to verify compliance with the quality agreement.

4.7 Dispute Resolution

1. Establish procedures for resolving disputes related to quality issues or non-compliance with the quality agreement.
2. Define escalation procedures if disputes cannot be resolved at the operational level.

5) Abbreviations, if any

SOP: Standard Operating Procedure

6) Documents, if any

Quality Agreements, Change Control Records, Audit Reports, Communication Logs, Performance Metrics Reports

7) Reference, if any

Regulatory guidelines and requirements related to quality agreements, such as FDA Guidance for Industry: Contract Manufacturing Arrangements for Drugs: Quality Agreements.

8) SOP Version

Version 1.0