GMP Trends and Analyses!

The leading journal for specialists and managers in pharmaceutical manufacturing and quality assurance

Covid-19: What Does Lockdown Mean for Chromatograph Qualification and Calibration?

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

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Focussing on Quality - Critical aspects for auditing IT suppliers and service providers

Why the auditing of critical IT technologies should have the same high priority as "classic" supplier audits. Please read more here

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Travel Restrictions: Are Remote Audits an Option

Travel Restrictions: Are Remote Audits an Option

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

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GMP-Update - What's new in Germany and the EU? - Part 2

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

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Benchmark of Industry Practices: Surface Cleanliness Monitoring

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

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Data Integrity & Data Governance Part 2: What does a Data Governance System look like?

In the second part of this series, you will learn how a data steering system should be structured. Please read more here

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Do you know the ECA Visual Inspection Good Practice Guide?

This ECA guide covers both the manual and automated process of visual inspection. Please read more here

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GMP: the growing issue of theft

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

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THE VALSARTAN CONTAMINATION - CONTEXT AND IMPLICATIONS

When Novartis's valsartan drug patent approached its end, a market worth several billions of US Dollars was to open its doors. Therefore other manufacturers of generic active pharmaceutical ingredients (API) were racing to develop their own synthesis processes of the substance - which may be an explanation for the contamination. Please read more here

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