Microorganisms are very diverse, multiple types, exist everywhere. How do we know we are working
with the right ones for quality, predictability, efficacy testing purposes, and more? We will briefly
discuss key definitions, principles and what global standards use and recommends. Stay tuned!
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.
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.
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.
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 have provided a comprehensive overview of the various strategies employed to ensure the integrity of pharmaceutical packaging and drug production.
The pharmaceutical industry is embracing digital transformation, especially in temperature monitoring. Shifting from manual temperature logs to real-time digital records has revolutionized efficiency and reliability. However, compliance with FDA 21 CFR Part 11 is crucial to maintain data accuracy and integrity. Discover the intricacies of this regulation in our comprehensive guide on temperature monitoring in pharmaceuticals.
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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