Blogs #patient safety
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.
Understanding Medical Device Software IEC 62304 Compliance
IEC 62304 compliance is essential for medical device software manufacturers to ensure safety, effectiveness & regulatory approval. It provides a systematic approach to software development, reduces risks & costs, and enhances product quality. However, developing medical device software is a complex process that involves ensuring regulatory compliance and meeting high standards for safety and effectiveness.
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.