McGee Pharma International

McGee Pharma International
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McGee Pharma International

 •  February 15

There is only one certainty in relation to Brexit at the moment and that is its current uncertainty! While it is evident that the UK and the EU have moved forward in their “divorce talks,” the final outcome of a post-Brexit trade relationship between both parties is still not clear. However, marketing authorisation holders should not wait to...

McGee Pharma International

 •  February 8

Top Tips to Avoid the Frequent FDA Form 483 Observations FDA Observations: While the regulations haven’t changed dramatically in recent years, the compliance expectation is ever increasing. The inspectorate’s use of computerised systems (e.g., Turbo EIR) allow inspectors to focus on industry trends and take a more risk-based approach. This leads...

McGee Pharma International

 •  January 31

As we near the end of January 2018, the date of 30th March 2019 is looming ever closer to end the UK’s EU membership and the application of all EU legislation in the UK will end with it. Two recent updates have been issued by the EMA in relation to Brexit and the position of UK pharmaceutical companies. EMA Survey Launch The agency issued news on...

McGee Pharma International

 •  January 22

In today’s pharmaceutical industry and increasing globalisation of pharmaceutical supply chains, the supply chain often extends across multiple transportation routes and regulatory jurisdictions. It may include sourcing pharmaceuticals from outside of the EU/EEA for distribution within the EU/EEA, or sourcing pharmaceuticals from within the EU/EEA...

McGee Pharma International

 •  January 19

First published in 1971, Annex 1 has been updated in target areas several times. However, this is the first time it has undergone a complete review. In recent years, it has become evident that the current Annex 1 has not kept pace with current regulatory and technological advancements and hence a complete review was necessary. According to European...

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...