GMP Trends and Analyses!

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

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

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

Read more …

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

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

Read more …

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

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

Read more …

FDA AND EU-GMP - ALWAYS IN BALANCE?

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

Read more …

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

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

Read more …

MRA - STRENGTHENING THE COLLABORATION OF FDA AND EU

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

Read more …

MODERN QUALIFICATION - WHAT DOES THAT MEAN?

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

Read more …

FIVE YEARS EU-GDP GUIDELINES - A SUCCESS STORY?

FIVE YEARS EU-GDP GUIDELINES - A SUCCESS STORY?

This year the GDP Guidelines, the guidelines for good distribution practice for medicinal products for human use, will be five years old. Looking back on these first years, one can observe very pleasing developments overall. And especially considering what the guidelines for medicines have brought to patients in terms of additional safety, they can be called a success story. Please read more here

Read more …

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

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

After the GMP world seemed to turn a bit slower in 2016, it picked up speed again last year - with some key changes that will also have an impact on German legislation. And even if the sheer number of new or revised specifications is limited, where there are changes, they are sometimes significant. Please read more here

Read more …

CAPA - SEVEN STEPS FOR AN EFFECTIVE PROCESS

CAPA - SEVEN STEPS FOR AN EFFECTIVE PROCESS

As the UK MHRA's Inspection Deficiency Data Trend Report for 2016 has shown, most of the deficiencies are related to the quality system - as in the year before. A sound CAPA programme can be a powerful tool to improve product quality, streamline production and ensure regulatory compliance. This requires seven steps. Please read more here

Read more …

To-Top
To-Bottom