A risk-based approach to scheduling audits.

Area of Science:

• Pharmaceutical Manufacturing
• Quality Assurance
• Supply Chain Management

Background:

• Pharmaceutical companies rely on diverse suppliers for materials and services, necessitating robust quality assurance.
• Traditional periodic audits are time-consuming and may not effectively guarantee supplier quality.
• Increasing audit burdens on third-party suppliers are leading to resistance and the need for alternative models.

Purpose of the Study:

• To present a risk-based approach for creating pharmaceutical supplier audit plans.
• To optimize the frequency and depth of audits based on quality risk management principles.
• To propose a shift from time-based to risk-based audit scheduling.

Main Methods:

• Application of the International Conference on Harmonisation (ICH) Q9 Quality Risk Management guideline.
• Development of a risk-based framework for audit planning and scheduling.
• Evaluation of audit frequency and depth based on identified risks.

Main Results:

• A risk-based audit approach can replace or extend intervals between time-driven audits.
• This model enhances patient safety and protects company reputation.
• The approach is scalable for both large and small pharmaceutical companies.

Conclusions:

• Implementing a risk-based audit strategy optimizes supplier quality assurance in pharmaceutical manufacturing.
• This flexible model addresses challenges with supplier audits, especially for smaller companies or those with monopolistic suppliers.
• The proposed framework can also inform regulatory inspection scheduling.