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A Four-Step Guide to Nitrosamine Risk Assessment and Mitigation

Discover the crucial steps pharmaceutical manufacturers must take to assess and mitigate nitrosamine risks in drug products. Learn how meticulous risk assessment, rigorous testing, and proactive strategies ensure product safety and global compliance. Read on to protect your patients and uphold industry standards!
Understanding FDA inspections is crucial for businesses in the food & drug industry. This blog breaks down the different types of inspections, the post-inspection process, and how to be prepared for a smooth FDA visit.
Dive deep into how nitrosamines, probable human carcinogens, can form during pharmaceutical manufacturing and the rigorous guidelines set by FDA and EMA to combat this risk. Discover the critical steps for risk assessment, testing, and mitigation that are ensuring drug safety worldwide. Don't miss out on this crucial industry insight!
Medicines undergo rigorous testing, but safety doesn't stop there. Post-Market Surveillance monitors medications once in use, identifying unforeseen side effects, changes in effectiveness, and off-label use. This data allows for updated prescribing information, further studies, or even product recalls, ultimately safeguarding public health.
Learn how to create clear and comprehensive technical documentation for Medical Devices (MD) and In Vitro Diagnostics (IVD). Whether you're new to the industry or have experience, this guide will help you master the art of technical writing in these fields. Discover the essential practices and expert tips for creating impactful documentation in these critical industries.
Discover how to streamline technical documentation for medical devices and in vitro diagnostic products in our insightful blog series. Part 1 delves into transforming complexity into clarity, paving the way for compliance in a dynamic regulatory landscape.
Periodic reviews are conducted throughout the operational life of computerized system to verify that it remains in a validated state, complies with current regulatory requirements, is fit for intended use, and satisfies company policies and procedures. The review should confirm that operational controls are in place and are being effectively applied.
For medical devices, where minor flaws endanger lives, a strong supply chain risk plan is essential. It prioritizes patient safety by mitigating risks like faulty parts or counterfeits and shows compliance with regulations.