The pharmaceutical industry is responsible for developing, manufacturing, and distributing life-saving medicines, making it one of the most complex and highly regulated sectors. However, the industry constantly faces challenges, including product quality, regulatory compliance, and… Read More »The Importance of a Well-Designed and Fit-for-Purpose Pharmaceutical Quality Management System
A regulatory inspection by the local competent health authority is a critical event that can have a significant impact on ongoing operations and is designed to indicate the level of quality, safety, and efficacy of… Read More »Preparing for a Pharmaceutical Regulatory Inspection: The Benefits of a Mock Inspection
The MHRA has published new guidance over the past few months on labelling and packaging following the agreement on the Windsor Framework. For those who are not aware, the Windsor Framework is the latest agreement… Read More »How the Windsor Framework will affect the supply of medicines in the UK and Ireland
Over the past couple of years, we have been asked on a few occasions to assist clients with new green-field pharmaceutical import and distribution operations in the EU. Ireland is often the location of choice… Read More »What are the requirements for setting up a GMP warehouse in the EU?
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has in place a guideline, ICH Q3D, to assess the risk of excessive exposure to elemental impurities in pharmaceuticals. ICH Q3D… Read More »ICH Q3D, what is it, and how is it used in the Pharmaceutical Industry?
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
