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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. The guidance document also emphasised semipermeable CCSs as another factor to consider in relation to E&Ls.

FDA 98
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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.

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Small Change: FDA’s Final Predetermined Change Control Plan (PCCP) Guidance Ditches ML and Adds Some Details, But Otherwise Sticks Closely to the Draft

The FDA Law Blog

The manufacturer should, in addition to stating whether the modification will be implemented manually or automatically, include details such as: End user actions needed, if any to implement the change, Timing of implementation, Extent of implementation in the install base, and Include references to expected labeling changes.

FDA 71