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sns34 replied to the topic Improving GMPs in the forum Quality Systems Management 7 years, 12 months ago
GMP is a regulatory framework which ensures that the production, processing, and packaging of medical devices is safe and effective. Companies that produce the devices must have procedures to comply with these regulations. Although I do not know an exact number to how often companies should improve/update their GMP requirements, I believe that systems, processes, and technologies must be kept up-to-date to comply with the latest regulations. Companies and employees are responsible for ensuring continual improvement in technologies, such as up-to-date records to show that procedures have been followed, traceable batches and distribution of products, validation of changes to procedures and processes, etc. Overall, a system or process that worked a decade ago may not be adequate to comply with today’s standards.