Standard Operating Procedure for Qualification of Contract Laboratories

1) Purpose

This SOP outlines the procedures for qualifying contract laboratories that perform testing, analysis, or other services related to pharmaceutical products to ensure compliance with quality standards and regulatory requirements.

2) Scope

This SOP applies to all contract laboratories engaged by the organization for testing, analysis, or other services related to pharmaceutical products, including active pharmaceutical ingredients (APIs), intermediates, and finished dosage forms.

3) Responsibilities

The Quality Assurance Manager or designated personnel are responsible for overseeing the qualification of contract laboratories. Procurement, quality control, regulatory affairs, and other relevant departments are responsible for implementing the procedures outlined in this SOP.

4) Procedure

4.1 Selection of Contract Laboratory

1. Identify the need for outsourcing testing or analytical services to a contract laboratory based on capacity, capability, and expertise.
2. Conduct a thorough evaluation and selection process to choose a suitable contract laboratory.

4.2 Qualification Criteria

1. Define qualification criteria based on regulatory requirements, quality standards, and specific needs of the organization.
2. Evaluate the contract laboratory’s capabilities, equipment, facilities, personnel qualifications, and compliance history.

4.3 Qualification Process

1. Initiate the qualification process by conducting a pre-qualification assessment or audit of the contract laboratory.
2. Review and assess the contract laboratory’s quality management system, procedures, and documentation.

4.4 Quality Agreement

1. Establish a quality agreement with the contract laboratory that defines roles, responsibilities, and expectations regarding testing, reporting, and compliance.
2. Specify quality standards, methods, protocols, and reporting requirements.

4.5 Performance Evaluation

1. Monitor the performance of the contract laboratory through ongoing evaluation, including review of testing data, proficiency testing results, and compliance with agreed-upon specifications.
2. Assess the contract laboratory’s adherence to timelines, communication, and responsiveness to issues.

4.6 Audit and Inspection Readiness

1. Conduct periodic audits or assessments of the contract laboratory to verify compliance with the quality agreement, regulatory requirements, and industry standards.
2. Ensure the contract laboratory is prepared for regulatory inspections and audits, providing necessary documentation and support.

4.7 Change Control

1. Implement a change control process to manage any changes to the scope of work, methods, specifications, or other aspects of the contract with the laboratory.
2. Ensure changes are communicated, documented, and approved by both parties.

5) Abbreviations, if any

SOP: Standard Operating Procedure

6) Documents, if any

Contract Laboratory Qualification Reports, Quality Agreements, Audit Reports, Performance Evaluation Reports

7) Reference, if any

Regulatory guidelines and requirements for outsourcing laboratory activities, such as FDA Guidance for Industry: Contract Manufacturing Arrangements for Drugs: Quality Agreements.

8) SOP Version

Version 1.0