• There are no suggestions because the search field is empty.

Life Sciences Blog

Whether you're in pharma, biotech, medical devices, or any other industry, our diverse services and expert guidance are designed to keep you informed and ahead of industry trends. Dive into our content and stay connected with the latest advancements and best practices.

Life Sciences Blog

Why-self-inspections-or-internal-audits-are-essential-for-your-QMS-1536x864
Circles_banner_news&events-1
Industry
Services
Filter
All
Services

GMP Annex 21: key requirements for importing medicines into the EU

In recent years, medicinal products for the EU market have been increasingly manufactured outside the EU. While this trend is particularly noticeable in...

Sub-visible particles in pharmaceutical products: understanding EP General Chapter 2.9.19

Ensuring the safety and quality of injectable pharmaceutical products is critical, and one key aspect of this is preventing particulate contamination

Analytical Method Transfer under GMP: tips & pitfalls

Analytical Method Transfers (AMTs) are a critical step in ensuring the reliable reproduction of validated analytical methods. These transfers occur...

How QPs Verify GMP Compliance for Non-EU Manufactured Products

Qualified Persons (QPs) play a crucial role in ensuring that medicinal products imported into the European Union (EU) meet Good Manufacturing...

Analytical Method Transfer: a practical step-by-step guide to compliance and efficiency

Did you know that performing an Analytical Method Transfer (AMT) can significantly benefit your laboratory? It’s a crucial process that allows...

ICP-MS vs ICP-OES analysis: choosing the right elemental impurity testing method

Elemental impurities in medicinal products and excipients are a major concern for regulatory authorities. The ICH Q3D guidelines set clear...

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...
data-not-found No Blog Post Found!
circle-box