European Pharmaceutical Review

JANUARY 25, 2024

Therefore, extractables and leachables assessment should consider the packaging components of the CCS, including the labelling. Moreover, manufacturers should document information about their safety thresholds, the guidance stated.

FDA 98

FDA Documentation Method Validation Packaging 98

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 52

Method Validation Documentation Packaging Compounding 52

The FDA Law Blog

FEBRUARY 13, 2025

The guidance encourages sponsors to engage with FDA using the Q-Submission Program prior to submitting a PCCP in order to obtain FDA feedback on if the proposed modification is suitable for inclusion in a PCCP and what information the PCCP will need to include. FDA may request additional information during the review of the PCCP.

FDA 71

FDA Documentation Labelling Method Validation 71