The Start of Internal Audit in Pharmaceutical Companies

Article By Mehrnaz Bozorgian , QA Specialist at Zamann Pharma Support

In the pharmaceutical industry, internal audits are a cornerstone of quality management and regulatory compliance. Establishing a robust pharma internal audit program ensures that processes remain efficient, risks are mitigated, and standards such as Good Manufacturing Practices (GMP) are maintained. This article provides a detailed overview of the initiation of internal audits in pharmaceutical companies, drawing on ISO 19011 guidelines, and discusses how to prepare an audit program and audit plan that drives success.

Understanding the Importance of Internal Audits

Internal audits serve as an independent review of an organization’s processes and controls. They are essential for:

• Ensuring Compliance: Verifying adherence to regulatory requirements (e.g., FDA, EMA) and internal policies.
• Risk Mitigation: Identifying areas of improvement and potential non-conformities before external audits occur.
• Continuous Improvement: Fostering a culture of quality and excellence by regularly assessing processes.
• Enhancing Efficiency: Streamlining operations by pinpointing process inefficiencies.

For pharmaceutical companies, the stakes are high. Even a minor lapse in internal controls can lead to product recalls, regulatory fines, or reputational damage. Therefore, establishing a structured internal audit program is critical.

ISO 19011: Guidelines for Auditing Management Systems

ISO 19011 provides internationally recognized guidance for auditing management systems. It lays out a framework that is highly applicable to the pharma industry. The standard outlines key steps for planning, conducting, and reporting audits. By adhering to ISO 19011, companies can ensure that their pharma internal audit processes are both effective and standardized.

Key Principles of ISO 19011

1. Integrity: Auditors must be objective and impartial, ensuring that audit outcomes reflect true performance.
2. Fair Presentation: Audit findings should be clearly documented and presented without bias.
3. Confidentiality: Information collected during audits must be protected and disclosed only as required.
4. Independence: Internal audits must be conducted independently of the activities being audited.
5. Evidence-Based Approach: Decisions and conclusions should be based on verifiable evidence.

For further details, consult the ISO 19011 Standard.

Steps for Initiating Pharma Internal Audit

Launching an effective internal audit program in a pharmaceutical setting involves several critical steps. Below, we outline the process as recommended by ISO 19011.

1. Preparation Phase

Define Audit Objectives and Scope

The first step is to clearly define the objectives of the internal audit. Consider what you aim to achieve:

• Compliance Verification: Are you confirming adherence to regulatory standards?
• Process Improvement: Is the goal to identify inefficiencies or potential risks?
• Quality Assurance: Will the audit help maintain product quality?

Documenting the scope is essential. It sets the boundaries for the audit and ensures that auditors focus on specific areas, such as production processes, quality control, or supply chain management.

Develop an Audit Program

An audit program is a high-level plan that outlines the schedule, frequency, and areas to be audited over a given period. Key components include:

• Annual Audit Schedule: List the departments or processes to be audited throughout the year.
• Resource Allocation: Identify the personnel, tools, and budget required.
• Key Performance Indicators (KPIs): Establish metrics to evaluate audit performance.

2. Planning Phase

Create an Audit Plan

Once the audit program is in place, detailed audit plans for each internal audit need to be developed. An audit plan should include:

• Audit Objectives and Scope: Detailed explanation of what will be audited.
• Audit Criteria: Standards, policies, and procedures to be used as benchmarks.
• Schedule and Timelines: Specific dates and timeframes for each audit activity.
• Team Assignments: Identify audit team members and their roles.
• Methodology: Describe the audit process, including data collection methods (e.g., interviews, document reviews, observations).
• Risk Considerations: Address any potential risks associated with the audit process.

A well-prepared audit plan ensures that audits are conducted in a structured manner and that all relevant information is captured.

Identify and Train Audit Team Members

Effective internal audits require a skilled team. The audit team should undergo regular training on:

• ISO 19011 Guidelines: Ensuring that auditors are familiar with the standards.
• Pharmaceutical Regulations: Updates on FDA, EMA, and GMP requirements.
• Audit Techniques: Best practices for interviewing, data collection, and analysis.

Providing ongoing training not only enhances the quality of the audits but also reinforces a culture of continuous improvement.

3. Conducting the Audit

With the preparation and planning phases complete, the audit itself can begin. Key steps during the audit include:

• Opening Meeting: Introduce the audit team, outline the audit scope, and set expectations with the auditee.
• Data Collection: Gather evidence through document reviews, interviews, and observations.
• Analysis: Evaluate the collected data against the audit criteria.
• Closing Meeting: Discuss preliminary findings with the auditee and agree on the next steps.

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