GMP Trends and Analyses!

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

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

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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

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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

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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

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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

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CONTI MANUFACTURING - THE CONTINUOUS MANUFACTURE OF TABLETS

CONTI MANUFACTURING - THE CONTINUOUS MANUFACTURE OF TABLETS

Systems for continuous manufacturing can be very compact, integrate many individual steps, thus ensuring fast turnaround times and reducing production costs. While such systems have already prevailed in the production of chemicals and foods, batch processes are still widely used in the pharmaceutical industry. The continuous manufacture of tablets is still in its infancy. Please read more here

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

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

In the manufacture of (bio) pharmaceuticals and medical devices, the cleaning and control of microbiological contamination are critical areas. Therefore, the disinfectants used, the frequency of their use and the rotation of (one or more) disinfectants together with a sporicidal agent should be scientifically justified by a formal microbiological risk assessment (MRA). Please read more here

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SERIALISATION: WHAT IS THE QUALIFIED PERSON'S (QP) ROLE?

SERIALISATION: WHAT IS THE QUALIFIED PERSON'S (QP) ROLE?

Until 9 February 2019, companies in the EU will have time to implement the safety features defined by the Delegated Act (Commission Delegated Regulation (EU) 2016/161) to verify the authenticity of medicinal products. So, what activities and systems need to be developed and implemented at a manufacturing site? And what role does the Qualified Person (QP) play in the tasks? Please read more here

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ANALYSIS OF BIOPHARMACEUTICALS – AUTHORITY EXPECTATIONS

ANALYSIS OF BIOPHARMACEUTICALS – AUTHORITY EXPECTATIONS

The term "biopharmaceuticals" comprises a very heterogeneous group of products - ranging from monoclonal antibodies, hormones, enzymes, plasma products and ATMPs to biosimilars. This results in several new challenges for manufacturers as well as for authorities to ensure the required safety and quality of the products in accordance with Directive 2001/83/EC. So what do the authorities expect? Please read more here

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CONFERENCE REPORT: TECHNICAL AND REGULATORY DEVELOPMENTS IN THE PHARMACEUTICAL INDUSTRY

CONFERENCE REPORT: TECHNICAL AND REGULATORY DEVELOPMENTS IN THE PHARMACEUTICAL INDUSTRY

In the 19th edition of the Pharma Congress end of March, lectures once again discussed the current regulatory developments and possible consequences for sterile medicinal products and their GMP-compliant production. According to the Congress' motto "Operators reporting for Operators", the speakers presented the current trends through many case studies. Please read more here

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