GMP Trends and Analyses!

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

Is Real Time Release Testing and Certification by the QP the next Generation Process?

Is Real Time Release Testing and Certification by the QP the next Generation Process?

RTRT is the ability to evaluate and ensure the quality of the product at the time of processing. Please read more here

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E-records Vulnerabilities

E-records Vulnerabilities

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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GMP Update 2020/2021 (NEW)

GMP Update 2020/2021 (NEW)

The work environment and focus of regulatory agencies have changed, in some cases significantly, in 2020, particularly as a result of Covid-19. Please read more here

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The FDA Warning Letter Report 2020

The FDA Warning Letter Report 2020

Facts, trends and important documents - An analysis of current warning letter. Please read more about the FDA Warning Letter Report 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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