This article explores six key regulatory updates in the European pharmaceutical and medical technology industries, highlighting the importance of staying informed and prepared for future changes.
In this article, we’ll explore how the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has shaped the landscape of regulatory compliance and fostered a more flexible approach to ensure the registration of safe, effective, and high-quality medicines worldwide.
To ensure a successful GxP outsourcing program, it is essential to proactively identify potential issues and implement strategies to mitigate them before they escalate into significant problems. Here are four valuable tips for effectively managing risk during GxP outsourcing:
In our latest article, we provide a comprehensive overview of the outsourcing process in the pharmaceutical industry. Discover how to maximize communication and oversight of your contracted operations to deliver real value to your organization
This article provides an overview of the European Union (EU) legislation and explains the licensing requirements for marketing pharmaceutical products in Europe.
Regulatory bodies are requiring more thorough investigations into supplier audits for pharmaceutical companies in order to ensure the highest quality of sourced products and services. Risk-based supplier audit plans provide a systematic and cost-effective method for examining current and potential suppliers, and this article looks into the definition, benefits, and factors to consider when implementing this approach.
Pharmaceutical industries are heavily regulated to protect patients from sub-standard or unsafe products. One way governments can do this is by requiring manufacturers to follow Current Good Manufacturing Practices (CGMP) to protect patients from dangerous products.
Read our latest blog to learn more about cGMP and their importance in the drug manufacturing industry.
Download our free Ultimate FMEA Guide, which is dedicated to GMP and pharma professionals.
This extensive yet simplified guide to Failure Mode and Effects Analysis (FMEA) will help you master one of the most vital instruments in your risk management toolbox.
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