Tag: GMP Regulations

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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