Sterile and aseptic manufacturing techniques have developed fast during the recent decade. With an increasing number of products manufactured with biotechnological methods, the importance of aseptic technologies and techniques have become more and more important for new and successful medicinal products. Attention is given by the regulators and inspectors in this field, which generally is considered as a technology of pharmaceutical manufacturing with immanent high risk.
As a consequence, the new Annex 1 to the EU GMP Guide was published in 2022 to be implemented in 2023. This Annex covers a key area of current and future activities and business in the pharmaceutical world and needs highest attention by those who do not want to experience a major set-back in receiving non-compliance assessments compared to their competitors.