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Labelling is one of the key points for our cosmetic product since it must have a minimum of information such as the batch or the quantity. Article 19 of Regulation (EC) Nº 1223/2009 tells us the minimum information that must appear on the labelling.   Some information does not have to appear on the labelling, […]

Ensuring better information on labelling and helping consumers make sustainable food choices is part of the “Farm to Fork” Strategy action plan. The European Commission intends to present a harmonised set of new rules on date marking by the end of 2022. Within the framework of the “Farm to Fork” strategy, the European Commission is […]

Manufacturers of cosmetic products are required to submit a Statement of Compliance to the Spanish Agency of Medicines and Medical Devices (AEMPS). The manufacturer is required to list all the activities for which it is responsible in this document, including its own activities and subcontracted work. This statement demonstrates that the manufacturer produces products in […]

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 […]

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 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 […]

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, […]