Phoenix Pharma
LabWare
BA Unternehmensgruppe
Reckitt
BIONTECH
ratiopharm
SANOFI
Boehringer Ingelheim
Biotest
Heraeus
Takeda
HAYS
UMM
STORCK
Torrent Pharma
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Service designed to assist clients in developing robust strategies for managing nitrosamine risks in drug products, ensuring compliance with ICH M7 and FDA requirements. We provide essential background documentation, including SOPs and internal guidelines, to guide clients in creating effective Risk Management plans.
Crafting a comprehensive framework for conducting Risk Assessments to identify potential nitrosamine impurities in drug products. Defining risk assessment criteria, methodologies, and decision-making processes to systematically evaluate and prioritize risks.
Collaborating with clients to develop customized mitigation strategies to control or eliminate nitrosamine impurities in drug products. Implementing risk control measures and preventive actions to minimize the likelihood of nitrosamine contamination during drug manufacturing and storage.
Conducting a detailed analysis of existing risk management practices to assess compliance with ICH M7 and FDA guidelines. Identifying deficiencies in current Risk Management processes and providing recommendations for improvement. Assisting clients in implementing enhancements to ensure alignment with regulatory requirements and industry best practices.
Our strategic approach to ensure Nitrosamine compliance is based on global and holistic experience, and can be perfectly adapted to your reality. We address the latest regulations and risk assessments, helping you manage and mitigate potential risks specific to your products and processes.
Zamann stays ahead of the evolving Nitrosamine requirements, providing expert guidance to ensure compliance with confidence. Our proactive and senior approach helps protect product integrity and patient safety, securing your operations against regulatory risks.
