GMP Trends and Analyses!

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

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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GMP Inspections at API Manufacturers in the EU and Asia

GMP Inspections at API Manufacturers in the EU and Asia

A report on last year's 21st APIC Conference on Active Pharmaceutical Ingredients. The event is the most important forum for manufacturers of active pharmaceutical ingredients and the pharmaceutical industry. Please read more here

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GMP UPDATE - WHAT'S NEW IN THE EU?

GMP UPDATE - WHAT'S NEW IN THE EU?

Anyone who believes that the biggest changes and upheavals in the GMP environment are through may be mistaken. Not only due to the current political impassability, such as the Brexit, things are in motion. Please read more here

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WHAT'S NEW IN THE GMP ENVIRONMENT?

WHAT'S NEW IN THE GMP ENVIRONMENT?

On 06-07 June 2019, the 8th European GMP Conference will take place in Heidelberg, Germany. This time, the Conference is also an opportunity for celebration - the ECA celebrates their 20th birthday at Heidelberg Castle. Please read more here

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GDP MEETS CAPA

GDP MEETS CAPA

Good Distribution Practice (GDP) Guidelines and Good Manufacturing Practice (GMP) Guidelines require organisations to implement effective Corrective Action and Preventive Action (CAPA) systems. Please read more here

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INADEQUATE HANDLING OF LABORATORY DATA AND OOS RESULTS

INADEQUATE HANDLING OF LABORATORY DATA AND OOS RESULTS

An analysis of warning letters involving active pharmaceutical ingredients over the last two years. Please read more here

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