Controlling cleaning agent residues in pharmaceutical manufacturing: A harmonized scientific strategy-Reference-Cited by-同舟云学术

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Controlling cleaning agent residues in pharmaceutical manufacturing: A harmonized scientific strategy

Published:2023-08 Issue: Volume:142 Page:105430
ISSN:0273-2300
Container-title:Regulatory Toxicology and Pharmacology
language:en
Short-container-title:Regulatory Toxicology and Pharmacology

Author:

Araya S.^ORCID,Pfister T.,Blum K.,Clemann N.,Faltermann S.,Wiesner L.,Hawkins W.,van de Gevel I.,Versyck K.

Publisher

Elsevier BV

Subject

Toxicology,General Medicine

Reference39 articles.

1. Cleaning limits—why the 10-ppm criterion should be abandoned;Ader;Pharmaceut. Technol.,2016

2. Nota Técnica No 276,2020

3. PDE concept for controlling cleaning agent residues in pharmaceuticals- A critical analysis;Araya;Regul. Toxicol. Pharmacol.,2022

4. ASTM E3219-20 Standard Guide for Derivation of Health-Based Exposure Limits (HBELs),2020

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