McGee Pharma International

McGee Pharma International
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The importance of Quality and Company Culture in 2018 Company Culture Company Culture and Quality Culture continue to be hot topics for the pharmaceutical industry into 2018. Culture is anchored in unspoken behaviours, mindsets, and social patterns. It underscores the way personnel interact with each other and with customers. Positive cultural...

McGee Pharma International

 •  December 21, 2017

The Mutual Recognition Agreements (MRA) that are in place allow EU authorities and their counterparts to rely on each other’s inspection system, to share inspection information and waive batch testing on importation. The MRA with the U.S. enters into force on 01st November but will be in transition phase until July 2019. But what does this...

McGee Pharma International

 •  December 12, 2017

Track and Trace – EU and US updates EU Serialisation Question and Answer Update On 22 November 2017, the follow-up version 8.0 of the European Commission’s questions and answer catalogue on practical implementation and technical aspects of serialisation requirements was published....

McGee Pharma International

 •  December 6, 2017

Building a pharmaceutical facility during drug approval stage can put companies in an extremely risky and costly position. Before you pour your concrete or sign your lease your best insurance policy is an independent GMP review of your facility design. Why waste money on remediating your facility after it has been built in order to meet GMP...

McGee Pharma International

 •  November 29, 2017

Many pharmaceutical companies would like to achieve a permanent state of so-called “Audit Readiness”. Most of the time, this kind of readiness is associated with a well implemented quality culture. It is part of the greater goal to establish a consistent and high GMP level. Maintaining regulatory compliance across the product lifecycle, from...

McGee Pharma International

 •  November 22, 2017

Contractors, suppliers and other 3rd parties play a key role in today’s modern pharmaceutical industry and the regulatory expectations for Quality Management of these vendors are increasing in response to the degree of the associated risks. Outsourced activities such as clinical trial management, manufacturing, analysis, warehousing, and...

McGee Pharma International

 •  November 21, 2017

On November 1, 2017, the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) announced that further aspects of the mutual recognition agreement between the European Union (EU) and the United States (US) were coming into...

McGee Pharma International

 •  November 16, 2017

Brexit – the stark reality is that the UK’s EU membership and the application of all EU legislation in the UK ends automatically at midnight on 30th March 2019! Current understanding is that a Withdrawal Agreement will be developed that will provide for withdrawal by the UK from various treaties and will outline the terms of the future relationship...

McGee Pharma International

 •  November 13, 2017

(EFPIA) survey into Brexit and the impact:
Last month, the European Medicines Agency (EMA) published its Brexit Preparedness Business Continuity Plan and has announced this week that it is getting ready for its relocation decision. The impact of the UK’s prospective withdrawal from the EU is not only significant for the EMA, but for the other EEA...

McGee Pharma International

 •  November 9, 2017

The requirement for QP oversight has been extended to material for use in clinical trials since the introduction of EU Directive 2001/20/EC. Annex 16 clearly states that the principles of the guidance also apply to Investigational Medicinal Products (IMP) for human use, subject to any difference in the legal provisions and more specific guidance...