GMP Trends and Analyses!

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

THE SPECIFIC CHALLENGES FOR THE IMP QP

To discuss the specific requirements for IMPs the European QP Association's IMP QP Working Group offered its first pre-conference as part of the 2007 QP Forum already. By now it has become a well-established part of the annual Forum and regularly attracts IMP QPs from all Europe. Please read more here

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THE NEW TREND IN THE GMP ENVIRONMENT: TRENDING

The objective of trending is forecasting possible events by projecting a pattern of data into the future. This trending is used in the regulatory environment in risk based approaches in inspections, but also in phase 3 of the process validation lifecycle - as lectures at this year's European GMP Conference illustrated. Please read more here

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GMP TRENDS: ANNEX 1, CONTINUOUS PRODUCTION AND CONTROL OF PARENTERALS

Past February the European Medicines Agency issued a concept paper on the revision of Annex I of the EU GMP Guide. The new version is supposed to be harmonised with the ICH Guidelines ICH Q9 and Q10, but should also take into account new technologies in sterile production that has not been considered so far. This current development was one of the main topics at this year's Pharma Congress where about 1.000 delegates from the European pharma industry met. Please read more here

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THE NEW ANNEX 15: A COMPREHENSIVE ANALYSIS

The draft of the revision of Annex 15 was published in February 2014. Some of the changes were significant. Recently this draft was issued as final document and became effective on 1st October 2015. What are the changes? Please read more here

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PULLING TOGETHER: API CONFERENCE AS INITIATOR FOR MORE HARMONISATION

Regulatory requirements are changing faster and faster, and they are becoming more and more complex. That's why personal contacts and the direct communication between industry and authorities are gaining in importance. It is the only way both are pulling together and to create some "harmonisation" - not only on the regulatory level. Please read more here

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ICH Q10: IMPLEMENTATION THROUGH TOTAL PROCESS QUALITY IMPROVEMENT

Part I described the changes needed for proper implementation of ICH Q10 objectives using transformative (Deming) quality cycles . This new part II now covers the product lifecycle process performance control through metrics based quality surveillance. Please read more here

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UPDATE: THE VISUAL INSPECTION OF PARENTERALS

The visual inspection of parenterals has been an intensively discussed subject for a while already. Now the EU GMP Guide Annex 1 is in revision, and the USP issued the long-awaited first draft of the chapter <1790>. Do they help to clarify what's still being discussed controversely? Please read more here

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GMP UPDATE - WHAT'S NEW IN THE EU?

In 2014 there were quite some new developments and announcements of changes in the GMP environment - and among them quite some that caused some agitation. Now these new and changed requirements need to be implemented. Please read more here

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A NEW CHANCE FOR AN MRA?

The continuously changing production landscape, the large number of production sites outside the US, medicinal product shortages are all among the factors that let the US FDA change their view: in future the authority will rely more on a quality culture much rather than merely inspect compliance with regulations. For that purpose the authority will be re-structured. Please read more here

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MICROBIOLOGY CONFERENCE ANS BIOBURDEN WORKSHOP PROVIDE FOOD FOR THOUHT

As in the years before the annual conference provided microbiologists with applicable knowledge and Know-how as well as food for thought for their daily practice. The preceding workshop concentrated on the regulatory background and practical examples and strategies for the control of bioburden. Please read more here

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