GMP Trends and Analyses!

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

Blind trust in supplier certificates and inadequate final testing

Blind trust in supplier certificates and inadequate final testing

Facts, trends and important documents - An analysis of current warning letter. Please read more here

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Particularities of Russian GMP inspections from a specialist interpreter's point of view

Particularities of Russian GMP inspections from a specialist interpreter's point of view

Many European pharmaceutical companies seek to enter the Russian market, but have little to no experience with the Russian authorities and their inspectors. Please read more here

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GDP for APIs - New ECA/PQG Guide

GDP for APIs - New ECA/PQG Guide

The new "Guidance on interpretation and implementation" of the ECA Foundation and Pharmaceutical Quality Group of the Chartered Quality Institute. Please read more here

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Pharma Congress 2020: Exchanging ideas and experiences online

Pharma Congress 2020: Exchanging ideas and experiences online

The Pharma Congress Production & Technology took place online for the first time this year. Here are some of its highlights. Please read more here

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

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

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

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

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

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

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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