Annex 1 Revisions: Understanding the Implications of European Commission's Updates

  •  5/30/2023 07:08 AM

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.

What is the difference between Asceptic Processing and Terminal Sterilization ?

  •  11/25/2020 11:08 AM

Aseptic process is carried out usually throughout the production and it also makes sure quality is built into it. It is carefully monitored all along to make sure that quality is built.