A GMP (Good Manufacturing Practice) audit is one of the key tools for ensuring quality in the pharmaceutical industry, aimed at verifying the compliance of production and control processes with applicable standards. In the face of increasing regulatory requirements and growing consumer awareness regarding the quality of medicinal products, preparing for a GMP audit has become a priority for pharmaceutical companies. It is not only a legal obligation but also an opportunity to improve internal processes and build trust with customers and business partners.

A GMP audit is a systematic process of assessing compliance with Good Manufacturing Practice requirements, which can bring numerous benefits to a company. Effective preparation for the audit and its professional execution not only help meet legal requirements but also serve as a valuable tool for early problem detection, process optimization, and improvement of the quality management system.

The purpose of this article is to provide a comprehensive overview of the steps involved in preparing for a GMP audit, with a particular focus on practical aspects that contribute to its success.

Delivering high-quality products and ensuring patient safety should be a priority for every pharmaceutical company. Companies must not only meet customer expectations but also comply with regulatory and registration requirements, which necessitates establishing, implementing, and continuously improving a quality assurance system based on GMP principles. Regular audits, both internal and external, are a key component in overseeing the effectiveness of this system.

This article provides detailed information on proper preparation for a GMP audit, as well as the benefits it can bring to a company. Key aspects are discussed, including the selection of the audit team, development of the audit plan, and preparation of the audit question list.

A GMP audit conducted in line with best practices not only ensures regulatory compliance but also facilitates the improvement of manufacturing and control processes, resulting in higher quality medicinal products and greater patient trust. A professional approach to the audit and proper preparation for the process form the foundation of effective quality management in the pharmaceutical industry.

I. Legal requirements

According to the Regulation of the Minister of Health on Good Manufacturing Practice, manufacturers are required to conduct regular internal inspections as an integral part of the Quality Assurance System. The purpose of these inspections is to evaluate the implementation and adherence to GMP principles and to take appropriate corrective actions in the event of identified non-compliances.

Manufacturers are obligated to archive reports of internal inspections and documentation related to corrective actions undertaken, in compliance with the procedures of the Quality Assurance System, for the period specified by regulations.

Additionally, written reports and records of internal audits must be prepared, documenting compliance with GMP principles and detailing actions taken to drive improvements. These reports should include final conclusions and information on the implementation of corrective actions.

II. Key definitions

GMP Audit: A systematic, independent, and documented process of gathering evidence. GMP audit evidence may include records, factual statements, or other verifiable information relevant to the audit criteria.

Audit Criteria: A set of policies, procedures, or requirements used as a reference against which audit evidence is compared.

Audit Findings: Results of the detailed assessment of collected audit evidence in the context of specified audit criteria. These criteria include policies, requirements, and procedures serving as the reference point for the audit.

Audit Conclusions: The outcome of the audit team’s analysis of audit objectives and findings. Conclusions may include recommendations for further actions, corrections, or improvements.

III. Purpose of GMP audits

GMP audits should be conducted to:

• Control, implement, and ensure compliance with Good Manufacturing Practice (GMP) requirements.
• Confirm the compliance of the Quality Assurance System built on GMP principles.
• Verify the manufacturing of medicinal products in relation to registration documentation.
• Identify necessary corrective and/or remedial actions.

Benefits of an audit for the company:

• Evaluation of Overall Quality Management: A well-functioning internal audit system provides a comprehensive view of quality-related issues within the company.
• Early Problem Detection: Audits allow the identification of issues before they impact product quality, enabling timely implementation of corrective and preventive actions.
• Reducing Rework and Product Rejections: Audits help identify errors and implement measures to prevent their recurrence.
• Improving the Quality Management and Assurance System: Audits provide valuable insights that aid in process optimization and the development of the quality management system.
• Providing Key Information to Management: Particularly important for pharmaceutical companies, audits deliver crucial data for decision-making.
• Enhancing Communication and Understanding of Quality Issues: Audits foster mutual training of auditors and auditees, leading to better comprehension of quality-related challenges.
• Self-Assessment Before External Audits (Certification) and Regulatory Inspections: Internal audits prepare pharmaceutical companies for inspections by regulatory authorities, such as the Main Pharmaceutical Inspectorate (GIF).
• Building Customer Trust: Regular audits demonstrate systematic control and continuous improvement of the Quality Management System, strengthening customer confidence.

IV. Establishing an audit team for GMP audits

An essential step in preparing for a GMP audit is selecting an appropriate audit team to:

• Define the scope, criteria, and objective of the audit.
• Appoint a lead auditor responsible for planning, conducting the GMP audit, and preparing the final report.

The selection of a competent audit team is critical, as auditors should:

• Possess knowledge of auditing practices.
• Be independent of the audited area.
• Exhibit high personal integrity and the ability to analyze situations effectively.
• Demonstrate sound judgment of audit criteria.

Collaboration within the audit team

Team cooperation is key to ensuring proper preparation and the efficient execution of a GMP audit. Effective teamwork enhances the quality of the audit process and its outcomes.

Key Principles for Auditors

• Conduct the GMP audit in accordance with best auditing practices.
• Objectively identify and interpret deviations from GMP standards.
• Promptly inform the auditee of critical non-conformities.
• Prepare an audit report.
• Assign corrective and/or remedial actions following the audit.

An auditor should serve not only as a controller but also as a mentor, supporting the company in achieving operational and systemic excellence.

At eCValidation, our GMP auditors:

• Have extensive experience and in-depth knowledge of the pharmaceutical industry, legal regulations, GMP guidelines, manufacturing processes, quality control, and technical aspects of the pharmaceutical sector.
• Are highly skilled and trained in conducting and leading audits effectively.
• Excel in planning and organizing work to ensure audits are completed within the scheduled timeframe.
• Uphold ethical conduct and maintain a professional approach.
• Use evidence-based methods to ensure rational and accurate assessments.
• Possess essential personal attributes such as reliability, integrity, observation skills, decisiveness, diligence, independence, and diplomacy.
• Maintain confidentiality and ensure the security of information obtained during audits.

V. Development of an audit plan

According to Good Manufacturing Practice requirements and ISO standards, internal audits (inspections) should be planned.
The audit plan should include at least the following elements:

• Audit number,
• Objective and scope of the audit,
• Criteria for the audit / reference documents,
• Name of the audited entity,
• Date and location of the audit activities,
• Time schedule,
• Composition of the audit team,
• Documents required to be presented during the audit,
• Signatures of individuals approving the audit plan (the audit plan must be agreed upon with those responsible for the audited area).

The audit plan outlines the audit details and identifies the areas and elements to be verified by designated auditors within a specific timeframe. It serves as a document that allows the audited party to prepare in advance for the GMP audit.

VI. Preparation of an audit question list

The audit question list serves as a support tool and guide for conducting a quick and effective GMP audit. It is a foundational element in preparing for the audit, enabling auditors to focus on critical aspects related to Good Manufacturing Practice (GMP).

This list is a compilation of questions prepared separately for each audit, taking into account knowledge of the manufacturer, specifying the audit structure, preventing the omission of any topics, providing a reference point, and assisting in the preparation of the audit report.

Thanks to this list, a GMP audit can be conducted logically—it serves as the foundation during the preparation process for the GMP audit.

It is important not to rigidly adhere to the audit question list, as each GMP audit is unique, and situations may vary depending on the company and current conditions or circumstances.

Practical approach to preparing for a GMP audit – key considerations

When preparing for a GMP audit, it is essential to include visits to the following areas:

• Raw material and packaging material warehouse,
• Production department (manufacturing, packaging),
• Control rooms in production areas (IPC),
• Quality Control Laboratories (including stability testing),
• Finished product warehouse,
• On-site sample archive.

As part of the preparations for a GMP audit (including developing a question list and familiarizing yourself with the specifics of the facility), the following issues and elements should be considered:

• Appearance/Condition of the Facility from the Outside:
• Appearance/Condition of the Buildings Inside:
• Raw Material and Packaging Material Warehouse:
• Sample Collection Area for Analysis:
• Manufacturing Area:
• Hygienic Airlocks:
• Controlled Substances:
• In-Process Control Rooms:
• Dedicated Product Packaging Rooms:
• Auxiliary Rooms:
• Storage Areas:
• Quality Control Laboratory (Physicochemical and Microbiological):
• Validation/Qualification:
• Finished Product Storage:
• Maintenance:
• Quality Assurance System Documentation:

The above considerations are critical and form the foundation for thorough preparation for a GMP audit in a pharmaceutical company.

Kamil Melson
Professional Validation Specialist