Author: digi

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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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…

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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…

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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…

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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:…

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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…

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