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Life Sciences Blog

Stay updated with the latest insights in life sciences! Our blog explores cutting-edge advancements, regulatory updates, and expert perspectives across pharmaceuticals, biotechnology, and medical devices. From innovation to implementation, discover valuable knowledge to support quality and compliance in the life science industry.

Life Sciences Blog

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The Risk of Benzene Contamination in Drug Products: What Manufacturers Need to Know

Benzene is a well-documented human carcinogen, and its presence in drug products poses a significant health risk. Benzene contamination can arise from...

Friability and disintegration for oral solid dose forms: the forgotten tests

Friability and disintegration testing are often overlooked during pharmaceutical development or testing; however, they play a certain role in getting...

Analytical Method Transfer: Common Pitfalls and How to Avoid Them

Analytical method transfers (AMTs) are a critical step in the drug-development timeline. AMTs often occur due to sequential activities, such as...

Elevate Pharma Imports with EU GMP Annexes 16 and 21

In the world of pharma imports, maintaining Good Manufacturing Practice (GMP) standards is a shared responsibility that transcends borders. The...

How to create a GMP-Compliant Stability Protocol?

Stability testing forms the cornerstone of pharmaceutical quality, ensuring that medicinal products retain their safety, efficacy, and quality throughout...

Importing medicinal products into the EU? A brief guide to EU GMP compliance.

In an era of increasing globalization, the pharmaceutical landscape is undergoing significant changes. This blog post offers a structured insight...

GMP-compliant design of climate or stability chambers: the key to ensuring product integrity

Stability testing serves as the backbone of regulatory compliance for pharmaceutical companies, providing crucial insights into the durability and...

4 Factors Influencing the Stability of Medicinal Products

Ensuring the stability of medicinal products is crucial for maintaining their effectiveness and safety throughout their shelf life. Numerous factors come...

The Importance of Stability Testing in Pharmaceutical Development

Stability testing plays a crucial role in the development of medicinal products, ensuring that they maintain their quality, safety, and efficacy throughout...

Compressed gases in pharmaceutical manufacturing: best practices in microbial monitoring

Compressed gas standards The latest draft of Annex 1, Manufacture of Sterile Medicinal Products, introduced the concept of a “contamination...

New GMP Annex 21 ‘Importation of Medicinal Products’ – Are you ready?

Current EU regulatory framework for MIA holders In recent years, medicinal products for the EU market are increasingly manufactured outside the EU ...
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