GMP Trends and Analyses!

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

THE 2011 FDA WARNING LETTERS REPORT

Unsatisfactory Validation of analytical Methods is the dominating Topic in the Warning Letters for API Manufacturers in the past fiscal year in which the US Food & Drug Administration issued a total of 14 Warning Letters to API manufacturers. Please read more here

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EVOLUTION: NEW ANNEX 11 SUPPORTS RISK-BASED APPROACH

After three years of waiting the new Annex II to European GMPs was issued. This document comes within the continuity of the first version by covering more exhaustively the system life cycle. A major evolution, based on ICH Q9 principles, this document takes into account and focuses on a risk-based approach. Please read more here

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BIO PRODUCTION FORUM MOVES R&D CLOSERTO INDUSTRIAL MANUFACTURING

With the subjects product development, process development and manufacturing the Forum successfully managed to build a bridge between research and industry. This year young scientists were invited for the first time to introduce their work in a poster session. Please read more here

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EUROPE's LARGEST PHARMA CONGRESS WITH COMPREHENSIVE EXHIBITION BRINGS TOGETHER INDUSTRY

In April 2012 representatives from the industry, from authorities and from suppliers will get together again for an information exchange at the Pharma Congress in Düsseldorf/Neuss. Please read more here

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EUROPEAN PHARMACEUTICAL INDUSTRY DEFINES EXPECTATIONS WITH REGARD TO EU PROCESS VALIDATION GUIDELINE

In the revision of the Process Validation Guidance the European Medicines Agency (EMA) wants to concentrate more on the product life cycle. What the industry thinks about this change was subject of a survey. Please read more here

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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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