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The European Commission has published a document of guidelines on EU regulations concerning single-use plastics providing guidelines on the interpretation and application of Directive (EU) 2019/904 of the European Parliament and of the Council dated June 5, 2019 on the reduction of the impact of certain plastic products on the environment. So as to reduce waste from single-use […]

Quality Audits are one of the main tools of the Quality Management System to check the status of compliance with the applicable regulations and propose the necessary ones corrective measures, despite the standard we are talking about (GMP, GLP, GCP, GDP, ISO 9001, ISO 13485, ISO 22716…), or the step of the product lifecycle (research […]

Marta Rodríguez Vélez | GXP Compliance & Safety Director | AZIERTA – July 2021   During the plenary session of the Spanish Parliament held on 10th June 2021 the constitution of the Health Subcommission was approved to study the regulation of the medicinal use of cannabis. This application is aimed at “analysing experiences of regulation […]

The science and health consultancy firm has supported the Catalonian pharmaceutical company in biosecurity areas Madrid, 11 May 2021 AZIERTA, a consultancy firm specialised in science and health, has completed a biosecurity project for the pharmaceutical company Reig Jofre, in order to ensure the biosecurity level necessary for handling the vaccine of the Belgium company Janssen Pharmaceutical, […]

Following Brexit and in order to avoid stock-outs in the UK, the MHRA has made exceptional procedures. – European Commission (EC) Decision Reliance Procedure: For a period of two years from 1 January 2021, when determining an application for a Great Britain Marketing Authorisations (MA), the MHRA may rely on a decision taken by the […]