GMP Trends and Analyses!

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

GOOD DISTRIBUTION PRACTECES: THE NEW GUIDELINE AND ITS CONSEQUENCES FOR INDUSTRY

In the past, when pharmaceutical companies had multiple manufacturing facilities and distributed their products locally, little attention was paid to product storage and distribution. Introduction of the EU GDP Guidelines in 1994 was an important first step, both for the regulators and for the industry. Now these Guidelines are being revised - bringing along some consequences for industry. Please read more here

Read more …

QBD IN THE LIGHT OF THE CURRENT PROCESS VALIDATION GUIDANCE

In the development of the pharmaceutical Quality by Design (QbD) process understanding and process control take a key role throughout a product's life cycle. This role constituted the centre of the discussions at the University of Heidelberg's QbD/  PAT Conference conducted last October.  Please read more here

Read more …

QUALITY AND SECURITY OF ACTIVE SUNSTANCES: HIGHLIGHTS OF THE 14th EUROPEAN APIC CONFERENCE

The 14th APIC Conference in Munich in November illustrated once again that the threat of patient safety due to inferior or falsified medicinal products is real and  increasing constantly. Due to this development effective counter measures by authorities  and associations are the more important - just as well as this conference as a  platform for exchanging information and bundling activities. Please read more here

Read more …

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

Read more …

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

Read more …

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

Read more …

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

Read more …

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

Read more …

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

Read more …

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

Read more …

To-Top
To-Bottom