GMP Services

25/05/2020

Here's my latest blog post on LinkedIn

I was honored to moderate a PDA Ireland Webinar last week and could see from all the questions asked, a lot of anxiety about remote auditing. Many were worried about how to provide the required information in a timely manner, but many were also concerned about the confidentiality of information when

23/05/2019

end of an era in Cork?

Thermo Fisher Scientific, which has been rapidly expanding its drug production, has yet another operation in its sights. It has struck a deal to buy a GlaxoSmithKline API plant in Ireland for €90 million in cash.

25/04/2019

Since the publication of ICH Q9 in 2005, it has become clear that there is a paradigm shift in the approach to Quality Management. We have moved from a compliance based system, where every requirement of the GMP regulations were implemented and applied with rigor, to a risk based approach.

28/01/2019

Great News
http://www.corkindependent.com/news/topics/articles/2019/01/28/4168398-depuy-investing-millions-in-research/

€36 million euro will be invested in projects that will focus on advancing material science in 3D printing, coatings and surface treatments to meet future needs.

23/01/2019

https://www.ft.com/content/3681be02-035d-11e9-9d01-cd4d49afbbe3

Drugmaker plans to split in two after spinning off consumer product unit

19/12/2018

Great News for Kerry

Central Pharma has announced plans to create 100 jobs in County Kerry over the next five years.

02/12/2018

HPRA comment on the Implant Files

‘The Irish Times’ part of global investigation – the Implant Files – into medical devices

01/12/2018

Great News
https://www.siliconrepublic.com/jobs/abbott-jobs-donegal

Pharma giant Abbott has confirmed that it plans to expand its workforce in Donegal with 500 new jobs.

26/11/2018

Safety of devices causing much discussion

A new report suggests eight deaths that might have been caused by medical devices were reported in the first nine months of the year.

24/10/2018

Health Products Regulatory Authority issues recall of 660,000 faulty defibrillators http://jrnl.ie/4304068

Three defibrillators manufactured by Philips Medical Systems are affected.

17/09/2018

2nd toxin found in recalled Valsartan

The US Food and Drug Administration said it found an additional

31/08/2018

Looking forward to speaking at PDA Irish Chapter event on Training in Process Simulation https://www.eventbrite.ie/e/advances-in-process-simulation-training-tickets-49288842254

05/07/2018

Major recall of blood pressure medication http://ow.ly/cOe230kOXUh

The objective of the Health Products Regulatory Authority is to ensure in so far as possible, consistent with current medical and scientific knowledge, the quality, safety and efficacy of medicines available in Ireland and to participate in systems designed to do that throughout the European Union.

19/06/2018

Ireland approved by FDA for MRA. The total number of countries accepted by the FDA is now 14: Austria, Croatia, France, Italy, Malta, Spain, Sweden, United Kingdom, Czech Republic, Greece, Hungary, Romania plus Lithuania and Ireland.

25/05/2018

More Great News!

Company employs about 170 people at its facility in Mulhuddart in Dublin

23/05/2018

Looking forward to HPRA's Medical Device information day

21/05/2018

Great News
https://www.irishtimes.com/business/health-pharma/gilead-sciences-launches-9-5m-unit-at-cork-plant-1.3502072?mode=amp&utm_source=dlvr.it&utm_medium=twitter

Biopharma firm’s Carrigtwohill quality control lab to boost output for overseas markets

16/02/2018

HPRA issue new Guidance for Medical Device Distributors http://www.gmp.ie/latest-news/

HPRA Issue Guidance on Distribution of Medical Devices The New Medical Device Regulations entered into force on 25 May 2017. The Regulations have a staggered transitional period. The obligations for distributors will apply with the full application of the Medical Device Regulation (MDR) after thr....