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.
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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.
The pharmaceutical industry relies on precise temperature storage to maintain product effectiveness and safety. Regulatory guidelines provide general principles, while organizations like the ICH and USP define specific temperature ranges. Adhering to these guidelines is crucial for minimizing risks and ensuring product integrity. Strict temperature storage protocols are essential for delivering safe and effective medications to patients.
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.
Our latest article delves into the nuances of FDA’s Form 483, offering essential guidance on how to transform FDA observations into concrete actions.
In this blog, we will delve deeper into the European regulations and guidelines that meticulously dictate the temperature storage requirements in the pharmaceutical domain. From understanding the basic principles to analyzing the nuanced details, we will provide you with a comprehensive guide to remain compliant throughout the entire lifecycle of temperature-sensitive products.
In an industry that is constantly evolving, it’s crucial to stay informed about the latest trends and updates. In this article, we shall journey into the heart of Good Manufacturing Practice (GMP) — reviewing the key changes and developments over recent years.
Choosing the Right Solution: 8 Factors to Consider for Successful Automation in Temperature Monitoring
Dive deep into the article below and explore the 8 crucial factors that should be taken into account when choosing automated temperature monitoring equipment.
Embark on an enlightening journey with us as we uncover the immense potential of automated temperature monitoring systems, and their transformative impact on your operations. We present a comprehensive 5-step guide to seamlessly integrate this revolutionary system into your daily processes.
Medicinal Product Falsification in the European Union: A Deep Dive into Packaging Safety Regulations
In this article, we will delve into the strategies, technologies, and collaborative efforts that are reshaping the landscape of pharmaceutical integrity and patient well-being in the European Union.