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!
Integration of Al in pharmaceutical manufacturing
Using artificial intelligence (AI) and machine learning (ML) are the most innovative technologies that are increased over the past few years in Pharmaceutical industry.
the integration of AI technologies holds great promise for accelerating drug development, improving patient outcomes, and revolutionizing the pharmaceutical industry
The analysis identified 103 different genera, including bacteria, molds, and yeast, with the top two frequently isolated microorganisms being Pseudomonas spp and Bacillus spp. Pseudomonas spp, gram-negative rods, are common in water sources and manufacturing settings, posing contamination risks in various industries. Bacillus spp, gram-positive rods with endospores, are prevalent in finished products and raw materials, playing a vital role in industrial biotechnology. Understanding these microorganisms is crucial for effective quality control and prevention of microbial contamination.
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.
Today, we invite you to explore a compelling case study that delves into the synergy between knowledge management and Quality Management Systems. Witness how this strategic integration doesn’t just bridge gaps; it creates pathways. As we navigate through this case study, you’ll uncover insights into how harnessing the power of knowledge can elevate an organization’s Quality Management System to new heights.
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.
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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