GMP Trends and Analyses!

02.04.2012

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

02.04.2012

THE ANTI-FALSIFICATION LEGISLATION: POTENTIAL CONSEQUENCES FOR QPs

By now, the annual QP Forum is one of the most important events for European Qualified Persons. Last December the Forum was conducted for the 6th time. Authority representatives as well as Qualified Persons with plenty of experience in the industry picked up currently discussed issues and shared their point of view - this time with 220 delegates. Please read more here

02.04.2012

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

03.10.2011

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

03.10.2011

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

03.10.2011

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

03.10.2011

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

03.10.2011

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

03.10.2011

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

04.04.2011

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