GMP Trends and Analyses!

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

TRENDS IN THE GMP/FDA COMPLIANT PHARMA PRODUCTION

The revision of the EU GMP Annex 1 for the manufacture of sterile medicinal products and its consequences for the pharma production and technology is currently among the most discussed topics in industry. This topic also determined discussions of the more than 60 speakers from the pharmaceutical industry and from authorities and the 1.000 participants who convened at this year's Pharma Congress end of April in Düsseldorf again to discuss the latest GMP/FDA trends. Please read more here

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ANNEX 1 - CLARIFICATION NEEDED

Last December the European Commission published the draft version of the update of the EU GMP Annex 1. This draft, which is roughly three times longer than the current version, was open for comments until end of March. At the Annex 1 Conference end of May 15 speakers and 200 participants subjected the draft a thorough analysis. Please read more here

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ANALYTICAL PROCEDURE LIFECYCLE MANAGEMENT - THE CHANGING FACE OF VALIDATION - FROM EVENT TO JOURNEY

In 2011, FDA revised their process validation guidelines to transform validation into a lifecycle process as apposed to an activity. This approach is consistent with EU GMP Annex 15. It is therefore desirable to use a similar model for analytical procedures. Please read more here

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GLASS PACKAGING: USP, EDQM AND ECA CONFERENCE COVERS CENTRAL ISSUES

In early June delegates and speakers from FDA, EDQM, USP as well as from industry concentrated on the latest developments with regard to glass packaging - at a conference jointly organised by the USP, Ph.Eur. and the ECA. Please read more here

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CLEANING AND DISINFECTION - A RISK BASED VS AN ARBITRAY APPROACH - PART II

Because cleaning and control are critical in the manufacture of (bio) pharmaceuticals and medical devices, a formal microbiological risk analysis (MRA) should provide scientific justification for why and how often a particular disinfectant was used and for how often and in which change further (sporicidal) agents may have been used. The second part of this article discusses the lifecycle approach for confirming the disinfectant rotation programme. Please read more here

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GMP UPDATE - WHAT IS NEW IN THE EU - PART II

In December, the GMP Update webinar summarized the latest developments and changes in the GMP area. In part II of the article you will find out more about the changes in some of the Annexes of the EU-GMP Guidelines as well about the latest news and related challenges with regard to the MRA agreement and what is going on around ICH Q12 and Q3D. Please read more here

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FDA AND EU-GMP - ALWAYS IN BALANCE?

Is the US FDA really much stricter, as you can frequently hear? To be able to answer this question, one has to take a look at the differences to the European GMP requirements - and the similarities. Because, after all, any company doing business with its products in the US market will need to be aware of the specifics. Please read more here

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RISK MANAGEMENT IN ICH Q12 - SUPPORTING QUALITY, COMPLIANCE & CULTURE EXCELLENCE OVER THE LIFECYCLE

Risk and knowledge management was primarily introduced by the ICH Guidelines (from ICH Q8 upwards). Now these areas are more and more appreciated and also implemented in other guidelines such as the EU-GMP Guide. The upcoming ICH Q12 guideline will show how - from an operational perspective - risk and knowledge management go hand in hand across the lifecycle of a product. Please read more here

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MRA - STRENGTHENING THE COLLABORATION OF FDA AND EU

The Mutual Recognition Agreement (MRA) - the Agreement on the Mutual Recognition of GMP Inspections of manufacturers of medicinal products for human use - between the EU and the US FDA has been applying since 1 November 2017. The purpose of this agreement is to increase the authorities' efficiency and thus to re-allocate resources for inspections in higher-risk countries. Please read more here

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MODERN QUALIFICATION - WHAT DOES THAT MEAN?

In the past the pharmaceutical industry initially struggled with implementing the regulatory requirements for qualification (and validation). The publication of the ASTM Guide and the revision of the Process Validation Guideline in the USA as well as the revision of Annex 15 in Europe changed that. Today there are alternatives. But what can these alternatives look like? Please read more here

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