Documentation, Labelling and Method Validation

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Documentation

Labelling

Method Validation

FDA guidance highlights E&L considerations for ophthalmic drug products

European Pharmaceutical Review

JANUARY 25, 2024

This document is revised from a version published in October 2023. Firstly, leachables can compromise a products quality and therapeutic effect, by potentially interacting with the formulated drug product, the document reported. Moreover, manufacturers should document information about their safety thresholds, the guidance stated.

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

Pharmacy Technician Pulse

FDA guidance highlights E&L considerations for ophthalmic drug products

Life-Cycle Approach to Cleaning Topical Drug Products

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