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)
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 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
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
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
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!
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 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?
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?
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
