Open Daily: 10am - 10pm | Alley door pickup 10am - 7pm 3038 Hennepin Ave Minneapolis, MN
612-822-4611

  • Open Daily: 10am - 10pm
    Alley-side Pickup: 10am - 7pm

    3038 Hennepin Ave Minneapolis, MN
    612-822-4611

Open Daily: 10am - 10pm | Alley-side Pickup: 10am - 7pm
3038 Hennepin Ave Minneapolis, MN
612-822-4611
EU-GMP Annex 1-2022 for sterile production with tips & hints: Guidelines applies to PICs and FDA

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

Bayegi, Parviz

Paperback

Chemistry

ISBN13: 9798300645304
Publisher: Independently Published
Published: Nov 20 2024
Pages: 168
Weight: 0.67
Height: 0.36 Width: 7.00 Depth: 10.00
Language: English
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.

Also from

Bayegi, Parviz

View All

Also in

Chemistry

View All