The leading journal for specialists and managers in pharmaceutical manufacturing and quality assurance
This article focuses on maintaining the calibration and qualification of chromatographs to ensure data integrity of results during the Covid-19 pandemic. Please read more here
Read more … Covid-19: What Does Lockdown Mean for Chromatograph Qualification and Calibration?
Why the auditing of critical IT technologies should have the same high priority as "classic" supplier audits. Please read more here
Read more … Focussing on Quality - Critical aspects for auditing IT suppliers and service providers
Marketing authorisation holders, manufacturers and clients must qualify their suppliers and contractors. An important part of such a qualification process is the performance of audits. Please read more here
Read more … Travel Restrictions: Are Remote Audits an Option
Highlights of APIC's 22nd API Conference in Prague. Please read more here
Read more … Nitrosamine Impurities - A Global Challenge for API Manufacturers and Pharmaceutical Companies
The secong part of this series on the changes in GMP regulations happening during the past year covers the EU-US MRA, Annex 1, ICH Q12 and more. Please read more here
Read more … GMP-Update - What's new in Germany and the EU? - Part 2
In the life science industry, surfaces pose different risks for the process depending on whether and how long they are in contact with the medicinal product. Please read more here
Read more … Benchmark of Industry Practices: Surface Cleanliness Monitoring
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?
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