Latest Insights

GxP Compliance

Biotech Products and the Challenge of Next Generation Cleaning Strategies

Cleaning Validation for Biotech products: our expert Marco Paolillo addresses the main challenges in the process.

GxP Compliance

What’s the “Cleaning Meaning”? The “5 Ws” of Cleaning Validation

Cleaning Validation in the Pharmaceutical Industry: our expert Marco Paolillo addresses the 5Wsv to avoid contamination and cross-contamination.

GxP Compliance

POINT OF CARE MANUFACTURE (POC): a new emerging model for innovative products

The Point of Care is a new approach for which drugs production sites should be as much close as possible to patients, to reduce the product lead.

GxP Compliance

How to perform a robust Vaccine Technology Transfer in a challenging era

Vaccine Technology Transfer is a core challenge for pharmaceutical companies that are involved in the fight to Covid-19.

GxP Compliance

Impact of possible removal of the Titanium dioxide from human medicines formulations was discussed during the CMDh meeting held on 14-17 September

The insight discuss the updated safety assessment of the food additive titanium dioxide (E 171) and experts concerns.

GxP Compliance

Covid Vaccine Technology Transfer: 5 reasons, risks, good practices

Find out from PQE experts how to perform a strong technology transfer to boost your vaccines production and meet compliance standards.

GxP Compliance

Covid-19 & Pharmaceutical manufacturing: the challenges for production quality, safety and continuity

Covid-19 impacts the daily routine of Pharma manufacturers, raising new challenges for employees’ safety and products’ quality.

GxP Compliance

CMDh raising risk awareness on Nitrosamines Impurities

Manufacturers of API and finished products should cooperate with MAHs to prevent nitrosamine formation and contamination of human medicinal products.