ISPE

JANUARY 11, 2023

Life-Cycle Approach to Cleaning Topical Drug Products Trudy Patterson Wed, 01/11/2023 - 10:17 Technical January / February 2023 Life-Cycle Approach to Cleaning Topical Drug Products Dijana Hadziselimovic Kamini I. The cleaning validation life-cycle approach consists of three stages: design, qualification, and continued verification.

Method Validation 52

Method Validation Documentation Packaging Compounding 52

European Pharmaceutical Review

JANUARY 25, 2024

Draft guidance published by the US Food and Drug Administration (FDA) in December 2023, discussed quality considerations for topical ophthalmic drug products, including key considerations for extractables and leachables (E&L) testing. This document is revised from a version published in October 2023.

FDA 87

FDA Documentation Method Validation Packaging 87

ISPE

MAY 9, 2023

CMC Requirements for New Drug Registration in Latin America Trudy Patterson Tue, 05/09/2023 - 11:23 Features May / June 2023 CMC Requirements for New Drug Registration in Latin America Aicha Otmani Flavia C. Most markets accept COAs from the registration batches (pilot or commercial scale) or commercial batches, if available.

Documentation 52

Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies 52