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A risk-based auditing process for pharmaceutical manufacturers.

Susan Vargo¹, Bob Dana, Vijaya Rangavajhula

¹Amgen, Inc., Longmont, CO, USA.

PDA Journal of Pharmaceutical Science and Technology

|March 27, 2014

Summary

This article proposes a risk-based model for scheduling internal and external audits, crucial for evaluating pharmaceutical manufacturers

Keywords:

Audit Quality systems Risk assessment Risk factors compliance

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Area of Science:

Pharmaceutical Manufacturing
Quality Management Systems
Regulatory Compliance

Background:

Pharmaceutical manufacturers must implement a comprehensive quality system.
Audits are integral to quality systems, assessing compliance status.
Current audit scheduling may not cover all critical areas.

Purpose of the Study:

To present a risk-based model for audit scheduling.
To enhance the efficiency and focus of internal and external audits.
To assist pharmaceutical manufacturers in identifying key audit areas.

Main Methods:

Discussion of risk-based scheduling approaches.
Identification of key focus areas for audits within the quality system.

Main Results:

Provides a framework for developing a risk-based audit schedule.
Suggests methods for prioritizing audit areas based on risk.

Conclusions:

A risk-based model optimizes audit scheduling for pharmaceutical quality systems.
This approach ensures a more targeted and effective evaluation of compliance.