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Investigational Medicinal Product

The role of Clinical EU Qualified Person – Anne Johnston (Q&A)

  • by Charley
  • March 4, 2023March 8, 2023

Orion GXP Consulting assists our clients by placing expert quality and regulatory contract professionals, tapping into our network of industry subject matter experts, including statutory roles such as EU Qualified Person and Responsible Person.  The… Read More »The role of Clinical EU Qualified Person – Anne Johnston (Q&A)

Risk Management

Applying Quality Risk Management principles in the pharmaceutical industry

  • by Charley
  • February 23, 2023February 23, 2023

Quality Risk Management (QRM) is the formal process where we identify, evaluate, and mitigate risks that are encountered when we manufacture and distribute medicines.  We do this using ICHQ9, which is the industry standard for… Read More »Applying Quality Risk Management principles in the pharmaceutical industry

The world of GXP

Importing Medicines into the EU

  • by Charley
  • January 29, 2023January 29, 2023

The new EU GMP Annex 21 came into force in August 2022 and is intended to summarize all EU GMP requirements applicable when importing medicinal products from outside the EU/EEA. If your company is importing… Read More »Importing Medicines into the EU

Focus on: Pharmaceutical Supplier or Contractor Qualification Audits

  • by Charley
  • March 29, 2023March 29, 2023

As we progress into spring 2023 and the audit season gets into full swing and following our successful Qualistery webinar on the topic, we wanted to highlight and talk about auditing and supplier qualification in… Read More »Focus on: Pharmaceutical Supplier or Contractor Qualification Audits

Tracable Warehouse

The illegal supply chain, counterfeiting and the Falsified Medicines Directive

  • by Charley
  • January 20, 2023January 20, 2023

As consumers, we are increasingly tempted to turn to online sources for medicines nowadays due to our changing shopping patterns and as a side effect of the recent pandemic. But, unfortunately, there are always those… Read More »The illegal supply chain, counterfeiting and the Falsified Medicines Directive

Risk Management

Orion GXP Consulting are hiring a Consultant QP!

  • by Charley
  • September 11, 2022September 11, 2022

Are you looking to dip your toe into contract QP work and get in at the beginning with new start-ups? Do you want to work just 2-5 days per week with a small number of… Read More »Orion GXP Consulting are hiring a Consultant QP!

Clinical Trials Regulation

Now that it has gone live, is the new Clinical Trials Regulation revolutionary?

  • by Charley
  • June 5, 2022June 6, 2022

The old Clinical trials directive 2001/20/EC was seen as bureaucratic and had many obstacles, such as not having a streamlined mechanism for authorising sponsorship of multi-centre studies to be carried out across the union. There… Read More »Now that it has gone live, is the new Clinical Trials Regulation revolutionary?

GMP Pharmaceutical Consulting

Why is good manufacturing practice so important in the Pharmaceutical industry?

  • by Lee
  • May 29, 2022May 29, 2022

GMP regulations require that all manufacturing processes must be documented and can be traced from beginning to end.  Complying with GMP guidelines makes sure that companies produce high-quality medicinal products for patients and ensures that… Read More »Why is good manufacturing practice so important in the Pharmaceutical industry?

Pharmaceutical Quality Management System – Off the shelf or mapped to your organisation?

  • by Charley
  • May 22, 2022May 29, 2022

With the often-tight deadlines to apply for marketing authorisations, Manufacturing and import authorisations and distribution licences to get a molecule to new markets or to expand operations into new GXP areas, it can be tempting… Read More »Pharmaceutical Quality Management System – Off the shelf or mapped to your organisation?

Remote working for the QP in the Pharmaceutical Industry

  • by Charley
  • May 18, 2022May 19, 2022

Hybrid and virtual work models are becoming the normality, so how does the pharma industry decide what is appropriate for the QP in manufacturing and virtual manufacturing/wholesaling operations?With the new rules from the HPRA allowing… Read More »Remote working for the QP in the Pharmaceutical Industry

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