It is crucial to validate the transport of medicinal products under representative conditions in order to ensure their quality, safety, and efficacy throughout the supply chain. The Good Distribution Practice (GDP) guidelines for medicinal products, which were introduced in 2013, place significant emphasis on safeguarding products during transportation to prevent risks such as temperature excursions, contamination, or damage. By following these guidelines for transport validation, stakeholders
This week, I want to delve into the processes involved in conducting clinical trials in the EU with a brief introduction to what clinical trials are and then to give an overview of the main guidelines and legislation. I will focus on regulatory frameworks, ethical considerations, and the steps taken to ensure public safety and trust.
The Product Quality Report (PQR), referred to as the Annual Product Review (APR) in the US, is a vital tool within the pharmaceutical industry, offering a systematic approach to maintaining oversight and controlling the quality of medicines.
Here at Orion GXP Consulting, we can assist our pharmaceutical clients when they need an extra pair of hands to manage their audit program. We have an extensive panel of highly qualified and experienced GMP auditors, including if there is a requirement for an audit by a Qualified Person or Responsible Person.