GMP Trends and Analyses!

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

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

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?

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

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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Medical Cannabis - How to get GMP-ready?

Medical Cannabis - How to get GMP-ready?

What does the legalisation of cannabis for medicinal purposes mean for national and international legal frameworks?

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GMP-Update - What's new in Germany and the EU? - Part 1

GMP-Update - What's new in Germany and the EU? - Part 1

The first part of this series on the changes in GMP regulations happening during the past year covers Nitrosamine Impurities. Please read more here

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FDA/GMP trends in production & technology - Part 2

FDA/GMP trends in production & technology - Part 2

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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Supplier Qualification and Outsourcing

Supplier Qualification and Outsourcing

Outsourcing is a critical process in the pharmaceutical industry. A whole series of quality assurance requirements are laid down in the corresponding GMP regulations. Please read more here

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Cold WFI Manufacture - Two Years after the Change in the Pharmacopoeia

Cold WFI Manufacture - Two Years after the Change in the Pharmacopoeia

Aft er almost a hundred years, the regulation for the production of water for injection (WFI) was changed in 2017. Please read more here

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Data Integrity and Data Governance - Part 1: What is Data Governance?

Data Integrity and Data Governance - Part 1: What is Data Governance?

An increase in data integrity and data governance observations during inspections made the development of new guidances on the subject neccessary. Please read more here

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Round table discussion on GMP for ATMPs in Vienna

Round table discussion on GMP for ATMPs in Vienna

The Round table discussion brought together representatives from authorities, industry and academia to exchange experiences on the GMP guidelines specific to Advanced Therapy Medicinal Products. Please read more here

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