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 services designed to equip clients with a comprehensive strategy for addressing Nitrosamine impurities in pharmaceutical products. We provide essential background documentation, including SOPs and internal guidelines, created to enable clients to meet the stringent requirements outlined by ICH M7 and the FDA.
We utilize established methodologies such as the ICH M7 guideline to develop a comprehensive risk assessment framework.
Tailoring the framework to the specific manufacturing processes, raw materials, and drug formulations of the client’s products. Incorporating industry best practices and scientific principles to ensure thorough identification and evaluation of nitrosamine risks.
Creating detailed SOPs that outline step-by-step procedures for detecting, quantifying, and mitigating nitrosamine impurities. Ensuring SOPs are clear, concise, and compliant with regulatory requirements, including those set forth by ICH M7 and the FDA. Collaborating with the client’s Quality Assurance and Regulatory Affairs teams to facilitate the smooth implementation of SOPs across manufacturing facilities.
Conducting a comprehensive review of existing documentation, including SOPs, validation reports, and analytical methods, to assess compliance with nitrosamine-related regulations. Identifying inconsistencies in documentation and recommending corrective actions to address deficiencies. We provide guidance on documentation updates and revisions to ensure alignment with regulatory requirements.
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.
