Azierta Blog

Ministerial Order SND/778/2023 of July, 10th “Regulating certain aspects of the authorization of industrially produced allergen-based medicinal products and bulk allergen-based medicinal products for human and veterinary use”. After months, Ministerial Order SND/778/2023 of July, 10th “Regulating certain aspects of the authorisation of industrially produced allergen-based medicinal products and bulk allergen-based medicinal products for human […]

In June 2018, authorities worldwide became aware of the presence of nitrosamines in several sartan drugs. Since then, significant concern has arisen due to the well-known carcinogenic potency of these impurities. Consequently, authorities have been continuously revising their guidelines based on the most up-to-date information. On July 7th, the EMA published the latest revision of […]

Residual solvents are unavoidable components in pharmaceutical production and will often be part of veterinary drugs. The target is to limit the amount of residual solvents in pharmaceutical products for the safety of the animal, as well as for the safety of residues in products derived from treated food-producing animals. They should not exceed the […]

Today we will talk about a topic of vital importance for the care of the environment: the Environmental Risk Report (ERA). Do you know what it is and why it is so important? If you don’t know, read on because here we will tell you everything you need to know about this report, so get […]

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 […]

One of the first steps executed by the EMA to prepare for the implementation of ISO IDMP will be the migration into the new PMS database.  The EMA has already started the migration of data from the current xEVMDP system for centrally registered medicinal products and will subsequently migrate the rest of the procedures (National, […]

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 […]