GMP Trends and Analyses!

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

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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FDA/GMP trends in production & technology - Part 1

FDA/GMP trends in production & technology - Part 1

First part of the Pharma Congress 2019 conference report: what has changed in the areas of continuous manufacturing, digitalisation, process optimisation, etc.? Please read more here

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Conference Report on GMP for ATMPs

Conference Report on GMP for ATMPs

The second ECA conference on GMP for Advanced Therapy Medicinal Products discussed important ATMP topics with speakers from authorities and the industry. Please read more here

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Knowledge Management

Knowledge Management

How knowledge management can be applied in order to use knowledge in an optimal way, to further develop it and to implement it in new products, processes and business areas. Please read more here

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When Things go wrong: is Whistleblowing an Option?

When Things go wrong: is Whistleblowing an Option?

What role does whistleblowing play in ensuring the compliance and patient safety of drug products and medical devices? How are QPs involved?

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Continuous Processing in the Biopharmaceutical Industry

Continuous Processing in the Biopharmaceutical Industry

Continuous processing is believed to be the next step for process intensification in the evolution of biopharmaceuticals.

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