In pharmaceutical and biotech manufacturing, changes to processes, equipment, or materials must be handled carefully. That’s why change control is a critical part of any company’s current Good Manufacturing Practice (cGMP) system. But when change con
In the medical device industry, safety isn’t just about the patients. It’s also about the people who make the devices, the workers. Many companies focus heavily on compliance and product standards, but a strong quality culture is what truly keeps bot
If you’re a manufacturer looking to sell your product in the European market, CE marking is a legal must. It’s more than just a label. It shows that your product meets the European Union’s health, safety, and environmental standards.But getting that
Every batch of pharmaceutical product starts with documentation. From raw material receipts to production logs, each step in manufacturing is recorded in batch records. On paper, this may look like a mundane task. In reality, those pages are vital to
Computerized Systems Validation (CSV) is a critical process in regulated industries like pharmaceuticals, biotech, and medical devices. It confirms that software and digital systems work as intended and meet all compliance requirements, especially th
Analytical labs play a central role in drug development and manufacturing. Whether testing raw materials, finished products, or environmental samples, the accuracy and integrity of lab data are vital for patient safety and regulatory compliance. That
ISO 9001:2015 is one of the world’s most recognized quality management standards. It helps organizations build reliable systems, improve consistency, and meet customer expectations. But a common question still comes up: Is ISO 9001 legally required?T
The holiday season can be a peaceful break for many, but for medical device companies, it can create challenges for maintaining compliance. With operations slowing, key staff taking time off, and regular routines being disrupted, staying aligned with
Creating a Quality Management System (QMS) for medical devices may seem complex, but it becomes much simpler with a step-by-step plan based on the ISO 13485:2016 standard. This guide explains the process in easy language to help companies meet intern
Clear hazard communication is essential in FDA-regulated workplaces. Whether it’s a pharmaceutical company, medical device plant, or lab, everyone must understand the risks around them. But the way hazard information is shared can differ based on a p
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