GMP Trends and Analyses!

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

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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TRENDS IN THE GMP/FDA COMPLIANT PHARMA PRODUCTION

TRENDS IN THE GMP/FDA COMPLIANT PHARMA PRODUCTION

The revision of the EU GMP Annex 1 for the manufacture of sterile medicinal products and its consequences for the pharma production and technology is currently among the most discussed topics in industry. This topic also determined discussions of the more than 60 speakers from the pharmaceutical industry and from authorities and the 1.000 participants who convened at this year's Pharma Congress end of April in Düsseldorf again to discuss the latest GMP/FDA trends. Please read more here

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ANNEX 1 - CLARIFICATION NEEDED

ANNEX 1 - CLARIFICATION NEEDED

Last December the European Commission published the draft version of the update of the EU GMP Annex 1. This draft, which is roughly three times longer than the current version, was open for comments until end of March. At the Annex 1 Conference end of May 15 speakers and 200 participants subjected the draft a thorough analysis. Please read more here

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ANALYTICAL PROCEDURE LIFECYCLE MANAGEMENT - THE CHANGING FACE OF VALIDATION - FROM EVENT TO JOURNEY

ANALYTICAL PROCEDURE LIFECYCLE MANAGEMENT - THE CHANGING FACE OF VALIDATION - FROM EVENT TO JOURNEY

In 2011, FDA revised their process validation guidelines to transform validation into a lifecycle process as apposed to an activity. This approach is consistent with EU GMP Annex 15. It is therefore desirable to use a similar model for analytical procedures. Please read more here

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