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.
Stay updated on latest GMP trends through our webinars and articles
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 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.
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.
Pharmaceutical Temperature Monitoring Compliance: Unraveling the Complex Web of Regulations and Guidelinesư
In this article, we delve into the differences between regulations and guidelines, highlight key examples from the FDA and European Commission, and provide practical recommendations for leveraging these directives effectively.
Welcome to our latest blog post, where we delve into the captivating story of a pharmaceutical giant grappling with the fallout of imperfect temperature management. This intriguing case study underscores the profound implications of temperature control in the pharmaceutical industry.
In this article, we will explore various security measures implemented in the industry to combat counterfeiting.
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 blogpost, we delve into the common challenges faced during audits and provide effective solutions to help you navigate through them. By implementing these strategies, you can transform the daunting prospect of audits into an opportunity for achieving audit success.
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.