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. Moreover, manufacturers should document information about their safety thresholds, the guidance stated.

FDA 98

FDA Documentation Method Validation Packaging 98

ISPE

JANUARY 11, 2023

Cleaning is an important component of a manufacturing process, and the process life-cycle approach should be followed for cleaning validation. The cleaning validation life-cycle approach consists of three stages: design, qualification, and continued verification. 1 US Food and Drug Administration. US Code Title 21: Food and Drugs.

Method Validation 52

Method Validation Documentation Packaging Compounding 52

ISPE

MAY 9, 2023

The information results from the authors’ experience working in a global company and managing successful drug registrations in the Latin American region. Additional required information beyond ICH guidelines, or non-value-added documents (e.g., the site where development occurs versus where commercialization is intended).

Documentation 52

Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies 52