GMP Trends and Analyses!

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

cGMP COMPLIANCE QUESTIONS TO AUTHORITY REPRESENTATIVES AND INDUSTRY EXPERTS :

During courses and conferences authority representatives and industry experts regularly answer questions from attendees - in this issue with respect to Annex II. Please read more here

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EUROPE's ANSWER TO COUNTERFEITING OF MEDICINAL PRODUCTS: DIRECTIVE 2011/62/EU

One of the central issues at the Conference "The new Pharma Directive" in October was the industry's fight against counterfeiting. By publishing the Directive 2011/62/EU the EU has issued a document extending the Directive 2011/83/EC with specifications for containing counterfeit medicines. Please read more here

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CHARTS: FDA WARNING LETTERS REPORT 2010

In the fiscal year 2009 the US Food & Drug Administration (FDA) had issued more Warning Letters to medicinal product manufacturers than in the years before. However, compared to the fiscal year 2010 the increase in the past years almost appears to be moderate. Please read more here

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FDA INSPECTIONS: PAST, PRESENT AND FUTURE

A global pharmaceutical supply chain and the quality issues as a result of this globalization, the 21st Century FDA initiative and resource constraints are changing the way the American authority envisions inspections of non-US production sites. Please read more here

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QUALITY BY DESIGN: THE REINVENTED WHEEL?

The International Conference on Harmonisation's considerations relative to quality by design lead to the ICH Guideline Q 8 "Pharmaceutical Development". What the pharmaceutical industry does not yet fully recognise, though, is the balance between rationality and pragmatism. Please read more here

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PERFORMANCE: HOW MUCH CONTAINMENT IS NEEDED?

As APIs are becoming more and more potent, as health and safety authorities worldwide increasingly pay attention to protecting operators dealing with these substances and as a decision on the optimal containment solution is more difficult due to the variety of solutions, containment frequently becomes an issue with regard to solid dosage form production. Please read more here

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INITIATIVES: QUALITY ASSURANCE FOR ACTIVE PHARMACEUTICAL INGREDIENTS

The pace of the globalisation of the API market has been tremendous, and authorities worldwide have not been able to keep up with expanding and harmonising their monitoring strategies. Some of the initiatives to confront the dangers of inferior or even counterfeit substances were introduced during the 13th APIC Conference in Barcelona last October. Please read more here

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CAPA AS A CENTRAL SYSTEM FOR IMPROVEMENT PROCESSES

Since CAPA has been implemented in guidances like ICH Q10 and the FDA Quality System Guide, the supervisory authorities' expectations also increase. An appropriate CAPA system provides the opportunity to continuously improve GMP processes. Please read more here

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INFORMATION EXCHANGE: PHARMA CONGRESS PRODUCTION & TECHNOLOGY 2011

After the enormous success of this year's Pharma Congress the industry's get-together will be further extended in 2011. In the next year the event will comprise five international as well as five German-speaking conferences. And at the accompanying exhibition more than 80 exhibitors will present their products and technology. Please read more here

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COUNTERFEIT MEDICINES: THE NECESSITY FOR A HARMONISED EUROPEAN APPROACH

According to the latest EU report the number of counterfeit medicine packs seized when entering Europe in 2009 increased to 11,5 million - impressively illustrating the need for a harmonised European approach. But what does this mean for those involved in the manufacturing process or in the supply chain? Please read more here

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