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Labelling

Method Validation

FDA guidance highlights E&L considerations for ophthalmic drug products

European Pharmaceutical Review

JANUARY 25, 2024

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

FDA Documentation Method Validation Packaging

Life-Cycle Approach to Cleaning Topical Drug Products

ISPE

JANUARY 11, 2023

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.

Method Validation

Method Validation Documentation Packaging Compounding

FDA guidance highlights E&L considerations for ophthalmic drug products

Life-Cycle Approach to Cleaning Topical Drug Products

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