GMP Trends and Analyses!

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

06.10.2008

GMP UNDER RECONSTRUCTION

During the second GMP Conference which took place in Heidelberg, Germany, in June 2007, it showed that the European Medicines Agency (EMEA) as well as the American Food & Drug Administration (FDA) intend to modernise the requirements relative to GMP fundamentally. But what has really changed since then? Please read more here

VOLUME I: PRE-FILLED SYRINGES

During courses and conferences authority officials and industry experts regularly answer questions from attendees - this time relative to pre-filled syringes. Please read more here