According to the Regulation, the main terms to be considered are as follows: Cosmetic product: any substance or mixture intended to be placed in contact with the superficial parts of the human body (i.e., epidermis, hair and capillary system, nails, lips, and external genitalia) or with the teeth and oral mucous membranes for the sole […]
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Quality Audits Management. What do we need to take into account? Auditing process optimization
Auditors’ qualification key point audit execution The training and qualification of the auditors’ team is a key point for achieving the best results during the audit program execution. The quality of the audit will depend mostly on the expertise and capabilities of the auditors. The audit team could be formed by any employee of the […]
Quality Audits Management. What do we need to take into account? Quality Audits managed according to QMS
Quality Audits Management System The Quality Audits should be managed according to the Quality Management System requirements, that should include: A risk based planification system for audits to be performed within a certain period of time. Effective training and qualification programs for the auditors, including clear requirements for their approval. A well defined system for […]
Single-use plastics for Food Supplements and Food
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 Management. What do we need to take into account? First approach, what is an audit?
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 […]
The Spanish Congress has created a subcommission to study the regulation of the medicinal use of cannabis
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 […]
AZIERTA Collaborates with REIG JOFRE to make possible the manufacture of JANSSEN’S Vaccine in Spain
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, […]
Consulting firms AZIERTA and PVPHARM sign strategic alliance in the are of Pharmacovigilance
The Partnership will work together to design and market advanced pharmacovigilance services in Spain and abroad. The Partnership will be the sector leader in Spain for providing comprehensive pharmacovigilance services and a European benchmark. Madrid, March 2020. AZIERTA, a global science and health consultancy firm specialised in accompanying the health industry in its scientific development, […]
Landing in UK: Following Brexit and in order to avoid stock-outs in the UK
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 […]
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