Compliance with Annex I Regulations: Three Key Considerations

New Annex I regulations for sterile drug manufacturing processes, monitoring, quality control, and more were published on 25 August this year. The new guidelines, the result of 16 years of work, are a significant departure from the original 2008 good manufacturing practices and are meant to reflect the realities of modern sterile manufacturing. The clock is ticking when it comes to updating your cleanroom protocols to become Annex I compliant, as the new regulations go into effect on 25 August next year.