McGee Pharma International

McGee Pharma International
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McGee Pharma International

 •  October 18

On 15 September 2017, the European Commission adopted two legal acts intended to update good manufacturing practice (GMP) requirements for investigational and authorised medicinal products in the EU. Based on Article 62 of new GCP Regulation 536/2014, it was required to revise the GMP requirements for investigational medicinal products (IMPs)....

McGee Pharma International

 •  October 10

Data Integrity has moved into the focus of many national and international regulatory inspections. Regulatory authorities such as the FDA, HPRA and MHRA are focused on ensuring that companies have a clear strategy on how the integrity of critical data can be assured over its complete life cycle. In a data integrity-focused audit, the emphasis has...

McGee Pharma International

 •  October 10

The European Union has established the Falsified Medicines Directive (FMD) Safety Features Delegated Regulation, meaning from early 2019, the serialisation of licensed drug products will be a legal requirement for companies in the EU. Serialisation will also become compulsory in the US from November 2017 in line with the US Drug Supply Chain...

McGee Pharma International

 •  October 10

Presented by Complya Consulting Group (A PharmaLex Company) As you may know by now, the days of Regulatory Operations teams pulling all-nighters printing, collating, and punching holes in paper submissions are nearing their end. Instead, those who love pagination and paper cuts will need to do those things on their own time, as mandatory electronic...

McGee Pharma International

 •  October 10

The UK’s referendum decision to leave the EU in May 2016 undoubtedly sent shockwaves throughout Europe. European countries are still struggling to interpret what ‘Brexit’ will mean for them. Ireland, as the UK’s closest neighbour both culturally and geographically, has been grappling with the potential impacts. However, there are potential major...

Hot Topics for User Access Management Challenges
Does your company experience challenges in relation to System Administrator User Access? This area was highlighted by HPRA findings for steriles and biologics in 2016 as presented at HPRA conference in February 2017. The observations were as follows: In relation to laboratory data integrity controls...

Marketing Authorisation Holder:
EU guidance states that the ultimate responsibility for the performance of a medicinal product over its lifetime, in relation to its safety, quality and efficacy, lies with the marketing authorisation holder (MAH). The MAH must have appropriate controls in place and operate a Quality Management System to support the...

Observation Overview:
Earlier this year, 2016 GMP inspection deficiency information was presented as part of GMP Conference by the HPRA. While a full breakdown of information or trend relating to deficiencies was not available, several examples of observations /deficiencies/ hot topics were cited. In relation to Eudralex Volume 4, data was...

The International Council for Harmonisation (ICH) met in Montreal, Canada on 27 May to 1 June At this conference the ICH Assembly approved the China Food and Drug Administration(CFDA) as a new Regulatory Member, and Pharmaceutical Inspection Co-operation Scheme (PIC/S)as a new Observer. In the last assembly, which occurred between 5-10 November...

McGee Pharma International

 •  September 21

The Life Science Industry The manufacturing industry in Ireland is now enjoying a renewed period of growth on the back of increased consumer demand in both Irish and overseas markets. This has also been matched by heightened levels of optimism throughout the sector. The IDA recently published an article on Advanced Manufacturing in Ireland. As part...