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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…
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…
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…
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…
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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:…
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,…
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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…
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…
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….
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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…
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