November 16, 2022

Trevalco Academy – online training

Our brand new Trevalco Academy is now live, offering online courses in validation, quality assurance and GMP compliance for the pharmaceutical industry. Trevalco Academy is our online training center through which anyone can subscribe to and follow digital, self-paced courses. We currently have 4 online trainings to offer, including two one-day trainings: We want to offer qualitative training at a reasonable price, which is possible because this is all training material we used at clients and for training of our […]
September 21, 2022

What’s in the new Eudralex Annex 1

A few weeks back the new and final version of Eudralex Volume 4 Annex 1 “Manufacture of Sterile Medicinal Products” was published on the website of the European Commission. This new version will come into operation on 25 August 2023, except for point 8.123 which is postponed until 25 August 2024. Where the current version of Eudralex Volume 4 Annex 1 is 16 pages, the new version has no less than 59 pages. The new EU annex 1 regulation provides […]
November 16, 2021

How to get more value from risk assessments in the life sciences industry

If you’re working in the life sciences industry you have probably been involved in risk assessments, maybe more often than you would have liked to. Whether you are working in a clinical development or pharmaceutical production environment, on drug products or medical devices, risk management has to be in place. This article will give you tips to make your risk assessments even better. One of the main reasons why risk assessments are so omnipresent is because in most cases they […]
August 30, 2021
regulations compliance

Audit trail requirements on GxP computerized systems

According to Wikipedia an audit trail is a chronological record providing documentary evidence of the sequence of activities that have affected at any time a specific operation, procedure, event, or device. The first uses of audit trails date back to ancient civilizations when rudimentary methods emerged to manage goods, soldiers and financial transactions. Audit trails to ensure data integrity came into the spotlight when US regulation 21CFR Part 11 was issued in 1997. Part 11 requires the use of secure, […]
February 20, 2021

Common FDA warning letter observations in 2020

Last year was a bizarre year and, hopefully, one of a kind. Not only did Covid-19 affect our personal and professional lives, it also had a huge impact on regulatory inspections which were delayed or executed remotely. In this article I present the main result of a data analysis on pharmaceutical FDA warning letters of 2020. I used the same tools as presented in one of my earlier articles on FDA warning letters. As shown on the pie chart below […]