Latest Insights

GxP Compliance

Inspection Readiness: What's Next?

Based on the 2023 EMA programming document, the forecast for the coming years is a recovery of coordination of inspections and certificate requests.

GxP Compliance

Inspection Readiness: Lessons Learnt from the Pandemic

Despite the tragic nature of COVID-19 pandemic, it is undeniable that several lessons have been learned from this ordeal.

GxP Compliance

Manual Visual Inspection

Manual visual inspection in pharmaceutical manufacturing is a critical process that requires careful risk assessment and mitigation. The FDA and.

GxP Compliance

Blockchain GAMP5 10

Blockchain technology can enhance compliance in the pharmaceutical field. What is the connection and how you can apply blockchain to your business?

GxP Compliance

MHRA Top 10 Inspection Findings

MHRA's top findings per chapter and E-book for download

GxP Compliance

Artificial Intelligence Learning algorithms validation in the context of GxP

How artificial intelligence can help with GxP compliance, and why companies should consider validating AI/ML GxP systems.

GxP Compliance

Shipping Validation and the Importance of the Cold Chain in the Pharmaceutical Market

What is Shipping validation under the GOOD DISTRIBUTION PRACTICE, and what is the importance of the cold chain in the pharmaceutical market.

GxP Compliance

Deviation Management

The deviation management process is a requirement and is designed to be a part of the Quality Management System (QMS) imposed by all major GMP.

GxP Compliance

Method Development in the EU

Method development as a key process to encompasses the process of establishing chemical analytical techniques.

GxP Compliance

Entering the EU Market of generics: products’ registration, do’s and don’ts

How to register a generic medicine in the European market?