Contract development and manufacturing organizations can assist sponsor company is ensuring sterility assurance in alignment with the EU’s Annex 1 guidelines. The 2023 revision of Annex 1 of the ...

Understand cGMP requirements for portable environmental monitoring to support contamination control in pharmaceutical cleanrooms.

Correction: This article was edited on 15 September 2022 to correct Jorg Zimmermann's title. Sterile drug manufacturers should start preparing a gap analysis to identify what needs to be done to ...

In the pharmaceutical industry, cleanrooms are categorized based on the level of airborne particle concentration necessary to meet the cleanliness standards required for the specific manufacturing ...

A new modification of the EU GMP Annex 1 regulatory standard for sterile drug products was announced in August 2022, substituting the most recent 2020 draft and the previous 2008 revision. The new ...