EU-GMP Annex 1-2022 for sterile production with tips & hints: Guidelines applies to PICs and FDA

In 2022, the European Medicines Agency (EMA), in collaboration with the PIC organization and the US FDA (cGMP), published a new EU GMP guideline that will come into force in 2023. The new Annex 1 is significantly more extensive than its predecessor and comprises 59 pages with 11 chapters. Chapter 8 in particular, with its 139 points on specific production processes, places high demands on manufacturers. In order to better understand and implement the complex content of the new Annex 1, a second column with technical explanations has been added to this book in addition to the original English text. These are based on decades of practice in production and quality management and offer valuable assistance for the practical application of the new guidelines.