Why Professional Audit Interpreters Are Essential for Cross-Border GMP Audits and Inspections in the Pharmaceutical and Medical Device Industries
17 January, 2025
Good Practice (GxP) audits are the cornerstone of regulatory compliance in the pharmaceutical and medical technology industries, ensuring the quality and safety of medicines and medical devices. Whether focused on GMP (Good Manufacturing Practice), GDP (Good Distribution Practice), GCP (Good Clinical Practice), GLP (Good Laboratory Practice) or GPvP (Good Pharmacovigilance Practice), they demand precise and accurate communication between the lead auditor and the host team. Given the global nature of the life science sector, quality assurance measures often involve assessing proprietary facilities or external suppliers in different countries. Language barriers can complicate this process, potentially causing delays or compliance risks....Read more
Good Practice (GxP) audits are the cornerstone of regulatory compliance in the pharmaceutical and medical technology industries, ensuring the quality and safety of medicines and medical devices. Whether focused on GMP (Good Manufacturing Practice), GDP (Good Distribution Practice), GCP (Good Clinical Practice), GLP (Good Laboratory Practice) or GPvP (Good Pharmacovigilance Practice), they demand precise and accurate communication between the lead auditor and the host team. Given the global nature of the life science sector, quality assurance measures often involve assessing proprietary facilities or external suppliers in different countries. Language barriers can complicate this process, potentially causing delays or compliance risks....Read more
Securing a European Union Marketing Authorisation for a veterinary medicinal product is a highly regulated process, designed to ensure that animal medicines meet rigorous standards of safety, efficacy, and quality. Introduced in 2022, the Centralised Procedure simplifies this process, enabling pharmaceutical companies to obtain approval across the European Economic Area with a single application. A fundamental, yet often neglected, aspect of this process is the Linguistic Review of Product Information translations coordinated by the European Medicines Agency. This article explores the key stages of reviewing and approving Product Information in 24 European languages for centrally authorised veterinary medicinal products, offering...
The import and distribution of pharmaceuticals within the European Union (EU) are governed by a stringent regulatory system designed to ensure that patients across the EU have access to high-quality, effective, and safe medicines. Within this framework, before any medicinal product can be placed on the EU market, it must undergo a rigorous authorisation procedure. A critical yet often overlooked component of this procedure is the Linguistic Review of Product Information translations. This article explores the key steps involved in this process for pharmaceuticals for human use, authorised for the European Single Market via the Centralised Procedure.
The European Medicines Agency has updated its veterinary product information template to support the implementation of the new Veterinary Medicinal Products Regulation which became applicable on 28th January 2022. In this article, we discuss what changes have been made, what triggered them, and what they mean for applicants and marketing authorisation holders of veterinary medicinal products.