Tag: GMP guidelines

Auditee: The maintenance and calibration of critical equipment within our manufacturing process are integral components of our quality assurance efforts. These practices ensure that our equipment functions accurately, consistently, and within the specified parameters, thereby contributing to the production of safe and high-quality pharmaceutical products. Maintenance Program: Our equipment maintenance program is designed to prevent…

Read More “How do you maintain and calibrate critical equipment used in your manufacturing process?” »

Auditee: Our facility’s organization, cleanliness, and measures to prevent cross-contamination are integral to maintaining a safe and compliant manufacturing environment. We prioritize these aspects to ensure the quality and integrity of our products while adhering to FDA regulations. Facility Organization: Our facility is thoughtfully organized to optimize workflow efficiency and minimize the risk of errors….

Read More “Show us your facility’s organization, cleanliness, and measures for preventing cross-contamination.” »

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…

Read More “Explain your process for handling and documenting deviations from established procedures.” »

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…

Read More “Provide examples of risk assessments you’ve conducted on your processes, products, and suppliers.” »

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…

Read More “How do you manage and document changes to processes, equipment, or materials?” »

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,…

Read More “Walk us through your procedure for investigating and addressing customer complaints related to product quality.” »

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,…

Read More “Can you show us how you handle and document product recalls, if necessary?” »

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…

Read More “Describe your supplier qualification process and how you ensure their compliance with FDA requirements.” »

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…

Read More “Show us examples of how you maintain and validate computer systems used in your manufacturing and quality processes.” »

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…

Read More “Demonstrate your procedures for conducting batch record reviews and ensuring their accuracy.” »