How to Interview During GMP (Good Manufacturing Practice) Audits In-house Training

Part of Audit Essentials: From Interviews to Inspections series:

Course overview

Ensuring compliance with Good Manufacturing Practices (GMP) is crucial for the safety and effectiveness of products, particularly in the pharmaceutical industry. A GMP audit plays a key role in verifying that these standards are being met, and interviews are one of the most effective tools auditors can use. They provide auditors with the opportunity to uncover operational insights, assess individual performance, and ensure that companies adhere to GMP requirements on a deeper level than just reviewing documents.

While audits generally rely on methods like observing operations, examining records, and reviewing documentation, interviews add an extra layer of depth. Each auditor may have a different style, with some preferring to engage directly with employees, while others focus on paperwork. However, for a GMP audit to be comprehensive, it is essential to integrate interviews, observations, document reviews, and record checks to create a full understanding of GMP compliance.

Interviews are particularly valuable because they allow auditors to understand the practical realities of manufacturing beyond what’s written in manuals. Discrepancies between documented procedures and actual practices may arise, and employees may reveal informal methods that deviate from the standard. With this training, you will learn how to identify these inconsistencies during interviews, empowering you, as the auditor, to make informed recommendations and ensure GMP standards are fully adhered to.

This course is part of our GxP training (Good x Practice) course collection, which features a variety of topic areas to ensure you comply with the most recent quality guidelines.

Benefits of attending

• Learn questioning techniques used to gather critical insights about processes, responsibilities, and compliance
• Improve critical thinking and analytical skills to draw accurate conclusions
• Identify deviations from documented procedures
• Discuss building a rapport and trust with employees to foster cooperation during audits
• Gain a deeper understanding of GMP regulations and how they apply to real-world processes
• Combine technical knowledge with interview techniques ensuring the audit process is more comprehensive
• Develop interpersonal and soft skills, such as active listening, empathy, and emotional intelligence

Who should attend

This training would suit those in the following departments:

• Quality Assurance
• Quality Control
• GMP Compliance
• Auditing
• IT
• Regulatory Affairs
• Engineering
• Supply Chain