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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...

Regulatory frameworks for Artificial Intelligence (AI) in the pharmaceutical and medical device industries are undergoing significant changes to meet the challenges and opportunities posed by this technology.

The pharmaceutical industry is rapidly evolving, and the number of AI application integrations is increasing day by day, reshaping every facet of pharmaceutical processes from drug discovery to supply chain management.

5 min read.

This is a story of triumph over tragedy. A story shaped by pivotal events that stress the importance of regulatory oversight in the production of pharmaceuticals and other medical products. This is the story of how the Good Manufacturing Practices (G...

5 min read.

Before a drug is suitable for patients, it must pass rigorous testing and cost-benefit analyses. In this post, we will discuss the journey a new medicinal product must take from the lab to final authorization in the EU. Continue reading this post to ...

5 min read.

We all know the EU GMP Annex 1 guideline: Manufacture of Sterile Medicinal Products. Yet manufacturing is evolving, and new technologies have emerged in recent years. It’s important that companies in the Life Sciences stay on top of these changes.

8 min read.

The pharmaceutical industry has a responsibility to prioritize sustainability, but unfortunately, it has not always done so in the past. At present, sustainability is often viewed as a trendy buzzword, used by companies to improve their public image ...

5 min read.

The pharmaceutical industry is one of the most rapidly evolving industries in the world, with new advancements and breakthroughs being made every day. Keeping up with the latest pharmaceutical industry news can be challenging, but fortunately, there ...

4 min read.

While the pharmaceutical industry continues to grow and evolve, GMP (Good Manufacturing Practice) compliance remains a top priority to ensure the safety and quality of products. Therefore, GMP is essential to every pharma manufacturing process to mai...

Even an organization with stellar leadership and a solid core of employees experiences hiccups from time to time. Despite having assembled all the ingredients for a great organizational culture or a superior product, a company or department is not li...

4 min read.

It is now well known by the Life Sciences community that the new version of EU GMP Annex 1, which was issued on 22nd August 2022, will come into force on 25 August 2023 (with the exception of chapter 8.123 "Product transfer/loading/unloading areas fo...

Every year, the FDA issues hundreds of warning letters along with inspections of manufacturing facilities. You should take the warning letters seriously because they act as a precursor to a worse failure. You should always take proper corrective and ...

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