The PIP scandal highlights the crucial need for stringent medical device regulation, exemplified by the Medical Device Regulation (2017/745). This crisis exposed the consequences of lax oversight in the industry.
A significant proportion of medicinal products, including vaccines and biologics, are temperature-sensitive, requiring stringent storage conditions. The cold chain is crucial in the pharmaceutical supply chain, ensuring careful management of temperature-sensitive products. Auditors play a vital role in scrutinizing cold chain management, ensuring adherence to regulatory standards. European regulations such as EU GMP and EU GDP guidelines, along with the WHO Model Guidance, provide comprehensive frameworks for manufacturing, storage, and distribution, safeguarding the quality and safety of pharmaceutical products. Compliance with these regulations is essential for protecting public health.
In this article, we have provided a comprehensive overview of the various strategies employed to ensure the integrity of pharmaceutical packaging and drug production.
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.
The use of digital technology in the quality assurance and control process can help standardize and streamline processes, making it easier to find potential issues and implement corrections. Automated systems can be used to monitor products, processes and documentation, and to perform tests more quickly and accurately.
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.
Learn about FMEA, a critical risk analysis tool and how to use it in the pharmaceutical 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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