Pharmaguideline is a RU-vid channel providing valuable information and insights related to pharmaceuticals. We educate and inform viewers about the pharmaceutical industry, including manufacturing, quality control, regulatory compliance, and product safety. Our channel provides comprehensive guidance on good manufacturing practices, laboratory practices, clinical practices, and relevant regulations and guidelines.
Our videos are created by industry experts with years of experience. We cover regulatory compliance, good manufacturing practices, regulatory audits and inspections, formulation, qualification, validation, quality management, and more. Our mission is to help professionals stay up-to-date with trends, best practices, and regulatory requirements. We provide accurate and reliable information to make informed decisions and achieve goals.
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🎯 Key Takeaways for quick navigation: Process validation ensures that a manufacturing process consistently produces products meeting predetermined specifications and quality attributes. Three stages of process validation in Pharmaceuticals are process design, process qualification, and continued process verification. Four types of process validation are prospective, retrospective, concurrent, and revalidation. Process validation helps determine process parameters, investigate deviations, minimize non-compliance risk, and reduce batch-to-batch variation. Implementing process validation leads to improved consistency, reliability, cost-effectiveness, customer satisfaction, and regulatory compliance. Made with HARPA AI
🎯 Key Takeaways for quick navigation: 00:00 *🏭 Process validation covers activities over the product and process life cycle.* 01:47 *📋 Types of process validation: Prospective validation before implementation, Retrospective using historical data, Concurrent monitors actual production.* Made with HARPA AI
If one batch passes it is assumed as unexpectedly passed, if 2 batches passes it is assumed as coincidence and 3 consecutive batches passes it is considered as consistent. So, 3 batches must be taken. It is acceptable by regulatory bodies.
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