The leading journal for specialists and managers in pharmaceutical manufacturing and quality assurance
In the second part of this series, you will learn how a data steering system should be structured. Please read more here
Read more … Data Integrity & Data Governance Part 2: What does a Data Governance System look like?
This ECA guide covers both the manual and automated process of visual inspection. Please read more here
Read more … Do you know the ECA Visual Inspection Good Practice Guide?
The quality, safety and efficacy of medicinal products depend on a whole range of different factors. Drug theft is an increasing issue here. Please read more here
Read more … GMP: the growing issue of theft
What does the legalisation of cannabis for medicinal purposes mean for national and international legal frameworks?
Please read more here
Read more … Medical Cannabis - How to get GMP-ready?
The first part of this series on the changes in GMP regulations happening during the past year covers Nitrosamine Impurities. Please read more here
Read more … GMP-Update - What's new in Germany and the EU? - Part 1
Second part of the Pharma Congress 2019 conference report: what has changed in the areas of data integrity, modern qualification, etc.? Please read more here
Read more … FDA/GMP trends in production & technology - Part 2
Outsourcing is a critical process in the pharmaceutical industry. A whole series of quality assurance requirements are laid down in the corresponding GMP regulations. Please read more here
Read more … Supplier Qualification and Outsourcing
Aft er almost a hundred years, the regulation for the production of water for injection (WFI) was changed in 2017. Please read more here
Read more … Cold WFI Manufacture - Two Years after the Change in the Pharmacopoeia
An increase in data integrity and data governance observations during inspections made the development of new guidances on the subject neccessary. Please read more here
Read more … Data Integrity and Data Governance - Part 1: What is Data Governance?
The Round table discussion brought together representatives from authorities, industry and academia to exchange experiences on the GMP guidelines specific to Advanced Therapy Medicinal Products. Please read more here
Read more … Round table discussion on GMP for ATMPs in Vienna
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