GMP Trends and Analyses!

05.04.2010

GAMP®5: COMPUTER SYSTEM VALIDATION IS UNDERGOING CHANGE

The processes recommended in the new Guide require a new way of thinking - especially in the quality assurance units of pharmaceutical manufacturers. Please read more here

05.04.2010

CONTROVERSIAL DISCUSSION: REQUIREMENTS OF ANNEX 1 CRIMPING / CAPPING

The requirements defined in the Annex 1 are still being discussed extensively. Now a PIC/S document may help companies to better interpret the requirements. Please read more here

05.04.2010

REVIEW: THE 12th EUROPEAN CONFERENCE ON ACTIVE PHARMACEUTICAL INGREDIENTS

Last November European API manufacturers and regulating authorities met in Venice, Italy, to discuss current GMP topics and regulatory issues. The openness on both sides clearly contributed to a further mutual understanding. Please read more here

05.10.2009

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

05.10.2009

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

05.10.2009

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

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