GMP Trends and Analyses!

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

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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GMP DOCUMENTATION

GMP DOCUMENTATION

One of the most discussed GMP topics in drug manufacturing is documentation. This article explains how several aspects of documentation are to be handled and discusses new PIC/S specifications. Please read more here

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THE VALSARTAN CONTAMINATION - CONTEXT AND IMPLICATIONS

THE VALSARTAN CONTAMINATION - CONTEXT AND IMPLICATIONS

When Novartis's valsartan drug patent approached its end, a market worth several billions of US Dollars was to open its doors. Therefore other manufacturers of generic active pharmaceutical ingredients (API) were racing to develop their own synthesis processes of the substance - which may be an explanation for the contamination. Please read more here

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