Quality in biopharmaceutical manufacturing is non-negotiable. Especially in today's cultural environment, biopharmaceutical quality management plays a crucial role in safeguarding product quality and maintaining the reputation of biopharmaceuticals. ...
In the pharmaceutical industry, maintaining patient safety and product quality is not just a regulatory obligation, it’s an ethical imperative. Any oversight can lead to severe consequences, from product recalls to harm to patients, tarnishing reputa...
Good Manufacturing Practices (GMPs) have been the cornerstone of quality assurance in pharmaceuticals and medical devices for decades. These guidelines ensure that every product, from medicines to medical devices, is consistently produced and control...
On November 25, 2020, the European Commission adopted the pharmaceutical strategy for Europe, an initiative that aims to transform the pharmaceutical landscape in the European Union.
Developing medical products is no easy feat. Most of these products are highly quality-sensitive and expensive. Naturally, most companies want to work with the best experts in the field, as there is little room for error. Consulting firms have steppe...
In the pharmaceutical and medical device industry, manufacturers must make sure medicines and healthcare products are made correctly, stored safely, and delivered to the people who need them. Supply chain management is the planning and organizing tha...
Pharmaceutical companies face numerous challenges when maintaining compliance, fostering innovation, and improving continuously.
Validation is the process of establishing documented evidence that a process or system is reliable and suitable to fulfill its intended purpose.
Pharma 4.0 is a framework for incorporating digital strategies into pharmaceutical manufacturing contexts. This framework envisions a manufacturing paradigm that allows manufacturers to change and iterate, connect resources and workers, simplify comp...
In the history of civilization and economic development, several industrial revolutions have brought about profound paradigm changes in society, economics, and culture, reshaping industries, creating new opportunities, and raising living standards fo...
The hype of artificial intelligence (AI) is revolutionizing industries such as pharmaceuticals and medical devices.
What is EU GMP Annex 11? EU GMP rules, also known as the ‘EudraLex rules’ govern the medicinal products in the European Union. The EU GMP rules are split into three different parts plus about 20 annexes. ‘The EU GMP Annex 11’ is one of the supplement...
Subscribe to the
Scilife Blog
Life Science and Quality resources and news. All directly to your inbox!
