GMP Trends and Analyses!

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

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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NEW STRATEGIES: THE FIGHT AGAINST COUNTERFEIT MEDICINES

The latest developments in the fight against counterfeit medicines were in the centre of attention at the ECA Conference "Strategies against Counterfeit Medicines" in Würzburg, Germany, last spring. Please read more here

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BIO PRODUCTION FORUM: BRIDGING RESEARCH AND INDUSTRY

In the past years the Bio Production Forum has been concentrating on taking a close look at the last stages of the development up to the production of biopharmaceutical products. As in the past years the conference this year again initiated the discussion of current regulatory developments and contributed to the understanding of the latest trends. Please read more here

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POINT OF VIEW: CHANGES IN THE CHAPTER ON TESTING NON-STERILE DOSAGE FORMS

What are the most important changes in the first revision of the chapter on testing non-sterile dosage forms and the proposed acceptance criteria and what do they actually mean? Please read more here

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IMPACT: THE MONOCYTE-ACTIVATION TEST (MAT) REDUCES THE RISK OF PYROGENICITY

In April 2010 the Monocyte Activation Test (MAT ) for the proof of pyrogenic substances has been included in the European Pharmacopoeia. This opens the chance for enormous progress with regard to ensuring that pharmaceutical products are free of pyrogenicity. Please read more here

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THE NEW PHARMA PACKAGE: FAR REACHING CONSEQUENCES FOR THE GMP ENVIRONMENT

The most important of three legislative proposals for the GMP environment by the European Commission is Part 3, dealing with combating counterfeit medicines as well as illegal distribution of medicinal products. Please read more here

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