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GxP Compliance

EU GMP Annex 11 Ch.4 & Annex 22: Latest EU regulatory updates

From data integrity to AI: the new EU GMP guidelines set a higher standard for compliance in the life sciences industry.

GxP Compliance

Pharma On The Road To Sustainability: Compliance & New Regulations

Pharma faces new regulations driving eco-friendly practices and ESG compliance for a sustainable future.

GxP Compliance

How to Manage and Mitigate Personnel Contamination Risks in Sterile Manufacturing

Learn how to manage personnel contamination risks in sterile pharmaceutical manufacturing and ensure product sterility and GMP compliance.

GxP Compliance

Remote Patient Monitoring Is Making Healthcare More Accessible Than Ever In The Digital Age

Remote Patient Monitoring is transforming healthcare by delivering continuous, accessible care and empowering patients beyond traditional settings.

GxP Compliance

FDA Expands Surprise Inspections: What Foreign Manufacturers Need to Know

The FDA expands unannounced inspections to foreign manufacturers: find out what this means for your company and how to prepare yourself

GxP Compliance

The Pharmaceutical Industry’s Path to Sustainable Development

This article covers the pharmaceutical industry's push for sustainability through ethical sourcing, innovation, and supply chain challenges.

GxP Compliance

Embracing Paperless Validation in a Fast-Evolving Life Sciences Industry

Embrace paperless validation to streamline workflows, enhance compliance, and reduce costs while meeting evolving regulatory standards in life.

GxP Compliance

Sterile Aseptic Processing – Stepping into the Future

Discover the limitations of RABS vs. isolators and why transitioning to isolator systems is essential for meeting evolving sterile processing GMP.

GxP Compliance

Process Harmonization & The Pursuit of Operational Excellence

Explore the importance of process harmonization in achieving operational excellence in the pharmaceutical industry.

GxP Compliance

FDA’s Pre-Approval Inspection (PAI) How to Prepare for a Successful Outcome – A PQE Case Study

Learn how PQE Group successfully prepared a Japanese client for FDA's Pre-Approval Inspection, leading to FDA approval in 2024.