Phoenix Pharma
LabWare
BA Unternehmensgruppe
Reckitt
BIONTECH
ratiopharm
SANOFI
Boehringer Ingelheim
Biotest
Heraeus
Takeda
HAYS
UMM
STORCK
Torrent Pharma
Menu
Services created to evaluate the existing strategies implemented by clients concerning nitrosamines and assess their compliance with ICH M7 and FDA regulations. We meticulously review SOPs, internal guidelines, and risk management practices to identify any GAPs or deficiencies and provide recommendations for improvement.
Conducting a thorough examination of SOPs, internal guidelines, and other relevant documents pertaining to nitrosamine risk management.
Assessing the adequacy and completeness of documentation in addressing ICH M7 and FDA requirements for nitrosamines.
Performing a detailed analysis of the risk assessment methodologies employed by the client to evaluate nitrosamine risks in pharmaceutical products.
Reviewing risk assessment criteria, data sources, and decision-making processes to ensure alignment with ICH M7 and FDA guidelines.
Identifying any discrepancies or non-compliance issues in the client’s nitrosamine risk management strategy concerning ICH M7 and FDA standards.
Highlighting areas where improvements or corrective actions are needed to enhance compliance and mitigate risks associated with nitrosamines.
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.
