GMP Trends and Analyses!

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

The long and winding Road of the Annex 1 Revision

The long and winding Road of the Annex 1 Revision

The first draft of the current revision was already published for comment on December 20, 2017. What has happened since then? Please read more here

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How to save Time and Money in International Equipment Qualification Projects?

How to save Time and Money in International Equipment Qualification Projects?

The regulations with regard to Qualification and Validation are different in the US, in Europe in China and other countries. Please read more here

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European GMP & GDP Forum – the largest Conference of its Kind in Europe

European GMP & GDP Forum – the largest Conference of its Kind in Europe

The first European GMP & GDP Forum will be held from 22-24 June 2021, both as an on-site meeting in Heidelberg, Germany, or Live Online. Please read more here

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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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