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Covering everything from the technology of particle counting to the regulatory standards that apply to the pharmaceutical manufacturing industry to the instrumentation and techniques needed to meet them, this premier handbook helps readers understand the topic of environmental monitoring more holistically and more extensively.
Annex 1 è una normativa che delinea i requisiti di produzione per i farmaci sterili fabbricati e importati nell’UE. Nell’agosto 2022 è stata rilasciata una nuova revisione dello standard normativo dell’Annex 1 GMP dell’UE per i prodotti farmaceutici sterili, che sostituisce la bozza più recente del 2020 e la revisione esistente del 2008.
As environmental system designers, we are often asked where to place sample points for particle monitoring, whether it be performed in a pharmaceutical cleanroom or clean device (RABS, isolator, etc.).
