Category: US FDA Mock Audits

Provide an overview of your process validation procedures for critical manufacturing processes.

Auditee: Process validation is a crucial step in ensuring the consistent quality and reliability of critical manufacturing processes. It involves a comprehensive evaluation of processes to demonstrate their capability to consistently produce products that meet predetermined specifications. Here’s an overview of our process validation procedures for critical manufacturing processes: Stage 1: Process Design Process Characterization:…

US FDA Mock Audits

How do you handle and document the disposal of non-conforming materials or products?

Auditee: Handling and documenting the disposal of non-conforming materials or products is a critical aspect of maintaining product quality, preventing their unintended use, and ensuring compliance with FDA regulations. Here’s how we handle and document the disposal process: Identification and Segregation: Non-conforming materials or products are identified through various quality control checks, inspections, or testing…

US FDA Mock Audits

Demonstrate your procedures for conducting batch record reviews and ensuring their accuracy.

Auditee: Conducting batch record reviews and ensuring their accuracy is a critical step in maintaining product quality, compliance with FDA regulations, and the integrity of our manufacturing processes. Here’s a demonstration of our procedures for conducting batch record reviews: Step 1: Document Preparation Batch Record Compilation: After each batch of product is manufactured, the batch…

US FDA Mock Audits

Show us examples of how you maintain and validate computer systems used in your manufacturing and quality processes.

Auditee: Maintaining and validating computer systems used in our manufacturing and quality processes is essential to ensure data integrity, compliance with FDA regulations, and the accuracy of our operations. Here are a couple of examples of how we achieve this: Example 1: Manufacturing Execution System (MES) Validation Planning Phase: Before implementing a new MES, we…

US FDA Mock Audits

Describe your supplier qualification process and how you ensure their compliance with FDA requirements.

Auditee: Our supplier qualification process is a comprehensive approach designed to ensure that our suppliers meet our quality standards, adhere to FDA requirements, and consistently provide materials and services that contribute to the production of safe and effective pharmaceutical products. Here’s an overview of our supplier qualification process and how we ensure compliance with FDA…

US FDA Mock Audits

Can you show us how you handle and document product recalls, if necessary?

Auditee: Handling and documenting product recalls is a critical process that requires swift and coordinated action to ensure patient safety, regulatory compliance, and effective communication. Our approach to managing product recalls is systematic and designed to mitigate risks while maintaining transparency and accountability. Recall Initiation: When a decision is made to initiate a product recall,…

US FDA Mock Audits

Walk us through your procedure for investigating and addressing customer complaints related to product quality.

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Auditee: Investigating and addressing customer complaints related to product quality is an integral part of our commitment to delivering safe and effective pharmaceutical products. Our procedure for handling customer complaints follows a structured approach to thoroughly investigate issues, implement corrective actions, and ensure continuous improvement. Complaint Receipt and Documentation: When a customer complaint is received,…

US FDA Mock Audits

How do you manage and document changes to processes, equipment, or materials?

Auditee: Managing and documenting changes to processes, equipment, or materials is a crucial aspect of ensuring product quality, regulatory compliance, and continuous improvement. Our change control process is designed to systematically evaluate, implement, and document changes while maintaining the integrity of our operations. Change Initiation: Changes can be initiated for various reasons, such as process…

US FDA Mock Audits

Provide examples of risk assessments you’ve conducted on your processes, products, and suppliers.

Auditee: Conducting risk assessments is a fundamental aspect of our quality management approach. We systematically evaluate potential risks associated with our processes, products, and suppliers to proactively identify and mitigate factors that could impact product quality, patient safety, and regulatory compliance. Process Risk Assessment: We regularly assess the risks associated with our manufacturing processes to…

US FDA Mock Audits

Explain your process for handling and documenting deviations from established procedures.

Auditee: Our process for handling and documenting deviations from established procedures is a critical aspect of maintaining compliance, product quality, and continuous improvement. Deviations, whether minor or major, are thoroughly addressed to identify root causes, implement corrective actions, and prevent recurrence. Deviation Identification: Deviations can arise from various sources, including equipment malfunctions, human error, unexpected…

US FDA Mock Audits