Phoenix Pharma
LabWare
BA Unternehmensgruppe
Reckitt
BIONTECH
ratiopharm
SANOFI
Boehringer Ingelheim
Biotest
Heraeus
Takeda
HAYS
UMM
STORCK
Torrent Pharma
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We offer specialized consulting services focused on preparing companies regarding Nitrosamines regulations in accordance with ICH M7 and international standards. Our service encompasses a thorough assessment of existing processes, the development of customized strategies, and the implementation of improvement initiatives to ensure compliance and enhance safety standards.
We conduct detailed risk assessments and GAP analyses to identify potential sources of Nitrosamine contamination in pharmaceutical products, raw materials, and manufacturing processes. Our experts evaluate existing control measures and assess the level of risk to determine necessary corrective actions and preventive measures.
Building on the findings from risk assessments, we collaborate with clients to develop Nitrosamine Life Cycle Strategies in compliance with the ICH M7 guidelines. This involves establishing control strategies, defining protocols for testing and monitoring, and implementing measures to prevent nitrosamine formation or contamination.
We provide comprehensive support and training throughout the implementation of Nitrosamine Life Cycle Strategies, ensuring adherence to ICH M7 guidelines and regulatory requirements. Our experts assist in implementing process changes, conducting training programs for staff members, and establishing robust monitoring systems to maintain compliance over time.
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.
