European Pharmaceutical Review

MARCH 6, 2024

Additionally, the new laboratory offers Ariceum the ability to carry out on-site process, method, validation and formulation development as well as preliminary stability analysis of its radiolabeled compounds.

Method Validation 96

Method Validation Compounding 96

ISPE

JANUARY 11, 2023

The cleaning validation life-cycle approach consists of three stages: design, qualification, and continued verification. Often referred to as the validation stage, stage two: qualification confirms that the cleaning procedure under normal conditions meets preestablished acceptance criteria.

Method Validation 52

Method Validation Documentation Packaging Compounding 52

European Pharmaceutical Review

JANUARY 25, 2024

Over time, these can leach “low molecular weight compounds” such as plasticisers, stabilisers and binding agents from CCS components or from labelling components, like inks or adhesives into the drug product. The guidance document also emphasised semipermeable CCSs as another factor to consider in relation to E&Ls.

FDA 94

FDA Documentation Method Validation Packaging 94

ISPE

MAY 9, 2023

Additionally, quality control testing of these compounds is conducted using standard testing following applicable pharmacopeia—such as United States Pharmacopeia (USP), European Pharmacopeia (EP), and Japanese Pharmacopeia (JP)—that was current at the time of testing.

Documentation 52

Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies 52