Remove Labelling Remove Method Validation Remove Packaging
article thumbnail

FDA guidance highlights E&L considerations for ophthalmic drug products

European Pharmaceutical Review

Therefore, extractables and leachables assessment should consider the packaging components of the CCS, including the labelling. However, according to the FDA, this is “less of a concern” for products, such as biological products, that are packaged in glass containers.

FDA 98
article thumbnail

Life-Cycle Approach to Cleaning Topical Drug Products

ISPE

Robbins 1 January 2023 Topical drug products and cosmetics are often manufactured in the same facility under a unified quality standard that supports the topical drug products’ performance and label claims. The cleaning validation life-cycle approach consists of three stages: design, qualification, and continued verification.