Category: US FDA Mock Audits

Provide examples of how you communicate with regulatory authorities, including the FDA, in the event of an audit or inspection.

Auditee: Effective communication with regulatory authorities, including the FDA, during audits or inspections is crucial to demonstrate transparency, cooperation, and compliance. Here are examples of how we communicate with regulatory authorities in such situations: Preparation and Notification Advance Notice: When we anticipate an upcoming audit or inspection, we promptly notify the relevant regulatory authority, such…

US FDA Mock Audits

Show us examples of your corrective and preventive action (CAPA) processes and how they’ve been implemented.

Corrective and Preventive Action (CAPA) processes are essential for addressing issues, preventing recurrence, and improving our quality management system. Here are examples of our CAPA processes and how they have been implemented: Example 1: Corrective Action Issue Identified: During an internal audit, it was found that a critical equipment calibration was overdue. Root Cause Analysis:…

US FDA Mock Audits

Explain your process for validating analytical methods used in quality control.

Auditee: Validating analytical methods used in quality control is crucial to ensure the accuracy, reliability, and consistency of test results. Here’s an explanation of our process for validating analytical methods: Step 1: Method Selection Method Identification: The specific analytical method to be validated is selected based on its relevance to the product, regulatory requirements, and…

US FDA Mock Audits

How do you ensure that your products meet FDA requirements for identity, strength, quality, and purity?

Auditee: Ensuring that our products meet FDA requirements for identity, strength, quality, and purity is a fundamental aspect of our operations. Here’s an overview of how we ensure compliance with these requirements: Identity Raw Material Verification: All incoming raw materials are rigorously tested and verified to confirm their identity, using validated analytical methods and reference…

US FDA Mock Audits

Describe your process for conducting internal audits and how you address findings.

Auditee: Conducting internal audits is a critical aspect of maintaining a robust quality management system and ensuring compliance with FDA regulations. Here’s a description of our process for conducting internal audits and addressing findings: Step 1: Audit Planning Audit Schedule: An annual audit schedule is developed, outlining the areas, processes, and functions that will be…

US FDA Mock Audits

Walk us through your process for handling and documenting employee training records.

Auditee: Properly handling and documenting employee training records is essential to ensure that personnel are adequately trained, competent, and compliant with FDA regulations. Here’s a walkthrough of our process for handling and documenting employee training records: Step 1: Training Needs Assessment Training Matrix: A training matrix is developed, outlining the roles, responsibilities, and required training…

US FDA Mock Audits

How do you ensure the integrity of electronic records and electronic signatures?

Auditee: Ensuring the integrity of electronic records and electronic signatures is crucial for maintaining data accuracy, security, and compliance with FDA regulations. Here’s an overview of our measures to ensure the integrity of electronic records and signatures: Access Control and Authentication Access: Access to electronic systems and records is restricted based on roles and responsibilities….

US FDA Mock Audits

Can you demonstrate how you monitor and maintain the quality and purity of incoming raw materials?

Auditee: Monitoring and maintaining the quality and purity of incoming raw materials is essential to ensure the integrity of our products and comply with FDA regulations. Here’s a demonstration of how we monitor and maintain the quality and purity of incoming raw materials: Step 1: Supplier Qualification Supplier Assessment: Potential suppliers are thoroughly evaluated based…

US FDA Mock Audits

Show us your procedures for maintaining and documenting environmental monitoring in manufacturing areas.

Auditee: Maintaining and documenting environmental monitoring in manufacturing areas is essential to ensure product quality, compliance with FDA regulations, and the integrity of our production processes. Here’s a demonstration of our procedures for maintaining and documenting environmental monitoring: Step 1: Monitoring Plan Development Area Classification: Manufacturing areas are classified based on their cleanliness requirements, and…

US FDA Mock Audits

Explain how you handle and document changes to product labeling and packaging.

Auditee: Handling and documenting changes to product labeling and packaging is a crucial process to ensure compliance with regulatory requirements, accurate information for consumers, and the integrity of our products. Here’s how we manage and document changes to product labeling and packaging: Change Initiation: Changes to labeling and packaging can be initiated for various reasons,…

US FDA Mock Audits