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 […]
Azierta Blog
Is your xEVMPD database ready?
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, […]
Update Annex 1: Manufacture of Sterile Medicinal Products
Key criteria to be considered
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 […]
Update Annex 1: Manufacture of Sterile Medicinal Products
Key criteria to be considered
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 […]
Main Changes revision ICH Q3D (R2) on elemental impurities guideline
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 […]
Azierta has attended Food 4 Future 2022
This week we are present in FOOD 4 FUTURE – EXPO FOODTECH 2022, with the aim of strengthening synergies and collaborations with the #agrofood sector. Ignacio Vieira, Care, Audits & Certifications, Health & Infrastructures, and DS&G Director & Jose Luis Prieto de la Hormaza, Key Account Manager have attended with the mission and value of continuing to explore opportunities […]
Inorganic impurities
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 […]
Azierta attending at Vitafoods Europe
Azierta has been present at Vitafoods Europe 2022, the most important event in the nutraceutical sector attended by experts from the health and nutrition industry from more than 100 countries. Vitafoods Europe is one of the most important business oriented nutrition fairs. During these days, the most important suppliers of ingredients and technology for dietary supplements […]
Azierta Care and the importance of diversifying markets
This month we interview Ignacio Vieira, Audit & Certification, Healthcare, DSG & AZ Health Consortium Director at Azierta who talks to us about AZIERTA CARE and the importance of diversifying markets. A talk in which our expert discusses the birth of the new unit, Azierta Care, its main services and its launch as an international boutique consultancy […]
Possible sources and classification of impurities
Impurities are defined in ICH Q6A guideline as “Any component of the drug product that is not the chemical entity defined as the drug substance or an excipient in the drug product. The impurities in drug products can be originated not only in the drug substance or inert ingredients used for formulating a drug product; […]