GMP Trends and Analyses!

05.10.2009

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

06.04.2009

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

06.04.2009

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

06.04.2009

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

06.04.2009

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

06.04.2009

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

06.04.2009

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

06.10.2008

IDEAS FOR THE BETTER PROTECTION OF EU PATIENTS AGAINST THE RISK OF COUNTERFEIT MEDICINES

To fight counterfeit medicines, it will be necessary to establish a series of requirements API and medicines manufacturers have to fulfil. The European Fine Chemicals Group (EFCG) has proposed some measures and has asked the Commission and the Member States to seriously consider their implementation. Please read more here

06.10.2008

COUNTERFEIT DRUG PRODUCTS - ACTION IN DEFAULT?

According to the World Health Organisation's (WHO) estimates, 8-10% of medicinal products worldwide are counterfeited. Only in Europe the macroeconomic damage amounts to 30 Milliard Euros. To get a grip on this problem it is necessary that all parties affected co-operate. Please read more here

06.10.2008

FDA'S NEW REQUIREMENTS ON PROCESS VALIDATION - AN OUTLOOK ON THE NEW FDA GUIDANCE

Industry has already been waiting for the new Process Validation Guideline as the current version has been effective since 1987. At the PAT Conference conducted in Heidelberg end of October, Jon Clark from the FDA gave an outlook on the revision. Please read more here