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Draft guidance published by the US Food and Drug Administration (FDA) in December 2023, discussed quality considerations for topical ophthalmic drug products, including key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 98

FDA Documentation Method Validation Packaging 98

European Pharmaceutical Review

JANUARY 26, 2023

The European Medicines Agency (EMA) has published an updated Q&A document regarding ICH M10 ‘Bioanalytical Method Validation and Study Sample Analysis’. The ICH M10 guideline provides recommendations on the validation of bioanalytical assays for chemical and biological drugs and their metabolites in biological matrices.

Method Validation 98

Method Validation Documentation FDA 98

ISPE

MAY 10, 2023

CoP Leader Profiles: Roujian “RJ” Zhang Trudy Patterson Wed, 05/10/2023 - 11:37 InTouch May / June 2023 CoP Leader Profiles: Roujian “RJ” Zhang Marcy Sanford 1 May 2023 Roujian “RJ” Zhang is Chair of ISPE’s new Quality Control (QC)/Analytical Community of Practice (CoP) Steering Committee.

Method Validation 52

Method Validation FDA 52

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.

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Method Validation Documentation Packaging Compounding 52

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. 21 Similarly, the FDA Center for Drug Evaluation and Research (CDER) began issuing electronic CPPs (eCPP) starting December 2021.

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Documentation Packaging Pharmaceutical Companies Pharmaceutical Companies 52