Toxicology

Workplace safety is of utmost importance, and any measure that can be taken to ensure the health and wellbeing of employees should never be overlooked. Occupational Exposure Limit (OEL) reports play a major role in this regard, as they provide detailed information about the potential hazards present when manipulating an API. In this blog post, […]

The EU GMP Annex 1 on “Manufacture of Sterile Medicinal Products” has finally been revised and published after several years. This new regulation states that its aim is: “provide general guidance that should be used in the design and control of facilities, equipment, systems and procedures used for the manufacture of all sterile products applying […]

The approval of the draft of Annex 1 Manufacture of sterile medicines seems to be getting closer every day. Since its issuance in 1989 has undergone some modifications, however, it had not been revised in its entirety. The latest version in force is from 2009. The second draft of February 2020 is the one that […]

The approval of the draft of Annex 1 Manufacture of sterile medicines seems to be getting closer every day. Since its issuance in 1989 has undergone some modifications, however, it had not been revised in its entirety. The latest version in force is from 2009. The second draft of February 2020 is the one that […]

In May , Revision 2 of the ICH Q3D guideline on elemental impurities in medicinal products for human use was published. The new revision has been adopted by the Regulatory Members of the ICH Assembly, although its effective date is set for September this year.   Main changes   1. Correction of PDEs: New PDEs […]

ICH Q3D   The first version of the ICH Q3D guidance was published in 2016, to control elemental impurities in medicinal products for human use within acceptable limits. For veterinary medicinal products, it was recently published in early 2020. The presence of elemental impurities in pharmaceuticals has traditionally been monitored by the so-called heavy metal […]

What steps should be taken to grow cannabis for medicinal use in Spain? And for the manufacture of active substances derived from cannabis? Can I grow cannabis in Spain and sell it to my customer in Germany? What do I need? These and other questions are common among companies who want to start their business in the […]

The will have to be updated according to the new European Regulation amending Annex II of REACH Madrid, 04 December 2020 – Azierta’s professionals Marta Rodriguez (Industrial Area Director), Ana María de Castro (Industry Science Manager) and Laura Puente (Senior Toxicology Officer) have reviewed in the last webinar organized by the company the new requirements to […]

  The webinar discussed the essential aspects of nitrosamines impurities, which can be carcinogenic and require manufacturers to evaluate their products. This Tuesday 27th October Azierta organized a professional webinar on nitrosamines impurities with 231 attendees. Ana Maria Castro, Industrial Area Manager, and Javier Fernandez, Senior Toxicology Officer, presented the content in two different blocks with special attention to the […]

1. Introduction In the last few years, elastomer, thermoplastic or thermostable plastic polymeric materials have become established as basic components in many pharmaceutical and biotechnological manufacturing processes. The range of polymeric materials available in the industry is very broad and materials have been developed with very different structural properties depending on the desired application. Some […]