GMP Trends and Analyses!

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

MEETING POINT: THE EUROPEAN QUALIFIED PERSON FORUM

Once every year Qualified Persons (QP) and other interested professionals from all over Europe meet to discuss the burning issues in their daily business. Today, the QP Forum is the central meeting point. Please read more here

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SAFETY ISSUES: THE MANUFCATURE OF APIs IN THE FAR EAST AND ITS SURVEILLANCE

One of the reasons for substandard APIs finding their way into medicinal products certainly is today's globalised and fragmented supply chain. However, the awareness for safety gaps as well as the efforts to close these gaps are increasing on both sides at authorities and in the industry. Please read more here

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FAST BREEDERS: RAPID MICROBIOLOGICAL METHODS (RMM)

In the last couple of months Rapid Microbiological Methods tremendously gained in importance. This development is certainly due to the increasing interest from all sides - from system manufacturers, industry as well as from authorities, and also showed in the number of attendees at a conference in Berlin, Germany, end of last year. Please read more here

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DIALOGUE: INDUSTRY MEETS AUTHORITY

The Heparin case and other incidents initiated a number of regulatory initiatives in the US and in Europe. These initiatives are supposed to take into account globalisation. To discuss the current developments representatives from industry and authorities met at the 3rd European GMP Conference in Heidelberg, Germany, end of June. Please read more here

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FDA'S JON CLARK INFORMS ABOUT THE AGENCY'S CURRENT INITIATIVES

How the FDA envisions to further contribute to a better quality of medicinal products by improving its regulations was presented by Dr Jon Clark during last year's Heidelberg PAT Conference. Please read more here

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FDA'S NEW PROCESS VALIDATION GUIDANCE - THE INDUSTRY PERSPECTIVE

Last November the new guidance was published as draft. Structured in seven chapters and on 20 pages the authority describes its "current thinking" regarding process validation. In a survey we asked whether and how it is already implemented. Please read more here

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FDA WARNING LETTERS REPORT 2008

Compared to the previous years the last year shows no significant variation in terms of subjects. In terms of numbers it's a different story though: a lot more companies did receive the red card last year. Please read more here

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COUNTERFEITING - A GLOBAL ISSUE

Counterfeit drugs are not only a problem in Africa or Asia any more. By now they are a potential threat to patients worldwide. The conference "Strategies against Counterfeit Medicines" last fall shed some light on this issue from various perspectives. Please read more here

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RISK-BASED QUALIFICATION OF SUPPLIERS, CONTRACT MANUFACTURERS AND CONTRACT LABS

According to the EC GMP Guide, manufacturers of medicinal products are not only obliged only to use GMP compliant APIs and excipients. They also have to evaluate contract manufacturers' and contract labs' qualification. As audits are rather extensive though, a risk-based approach increasingly gains in importance. Please read more here

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THIRD EUROPEAN GMP CONFERENCE - A UNIQUE FORUM

After 2005 and 2007 the GMP world gets together for the third time in Heidelberg. The programme: the latest developments in GMP, a vis-à-vis of industry and authorities in five parallel "sessions" and the celebration of the 10th anniversary of the ECA. Please read more here

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