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Annex 1 Revisions: Understanding the Implications of European Commission's Updates
Annex 1 of the European Union GMP document provides specific guidance on the production of sterile medicinal products, covering various aspects such as facilities, equipment, validation, environmental monitoring, and personnel. Its aim is to establish a harmonized approach to ensure the highest quality standards throughout the manufacturing process.
Why is Quality by Design (QbD) important?
QbD is an essential concept in the pharmaceutical and medical device industries, as it ensures that products are safe, effective, and meet the needs of patients. By implementing QbD, manufacturers can reduce the risk of product recalls, improve the efficiency of the manufacturing process, and develop innovative products that meet the needs of patients and stakeholders.