PQE Group

Latest Insights

Medical Device

New Extension on the Regulation of MD and IVD Transition Periods

The European Commission proposed to extend the certification period for medical device suppliers by 4 years to avoid shortages. Are you compliant?

Regulatory Affairs

Elemental Impurities in Veterinary Medicinal Product

In January 2023, the implementation of risk assessment requirements to control elemental impurities in veterinary medicinal products will enter into.

Annex 1

From Reasoning to Specifics: New GMP EU Appendix 1

The updated GMP EU Appendix 1 finally came about in August 2022. Its application is the fundamental backbone for manufacturers of medicinal products.

Annex 1

Interview with Annex 1 Expert - Giovanna Cantoni

Watch the interview with PQE Group Annex 1 Expert Giovanna Cantoni

CSV & Data Integrity

GAMP® 5 Guide 2nd Edition Release

Gamp 5 Version 2 released in July 2022 brings new updates for computerized systems in the Life Science industry.

Regulatory Affairs

Are you ready? Have you implemented EU ISO IDMP standards for medicinal products?

Are you ready to implement the EU ISO IDMP standards for medicinal products? Discover with us how to safely move to the new standards

Medical Device

Israel MDSAP Affiliate Membership

The Ministry of Health of Israel has just been included in the Medical Device Single Audit Program (MDSAP), what are the changes?

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.

Regulatory Affairs

Food Supplement notification procedure changes

Effective June 30, 2022, the registration procedure for Food Supplement notification in Italy has changed.

IT Operations

Cloud Computing in a Regulated Environment

Regulated companies are moving to Cloud solutions to store data, improving their performance and capability, while keeping a careful GxP oriented.