Alberto Carazo

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1. Introduction The procedures, cleaning frequency  and indicated maintenance are illustrative. The user must establish standardized procedures and frequencies in specific work procedures , according to the experience with the equipment and the historical incidents. 2. Cleaning and disinfection of […]

Blog Alberto Carazo Pharmaceutical support 0 comentarios 13 - 01 - 15

Good Manufacturing Practices (GMP) in the production of cosmetics

1. Introduction The requirements in the cosmetic sector are defined in the regulation of the CE Nº 1223/2009 of the European Parliament and of the Council about cosmetic products that was published in the Official Journal on December 22, 2009, […]

Blog Alberto Carazo Sin categoría 0 comentarios 13 - 01 - 15

New EMA Guide: Definition of the limits of exposition for the risk analysis in multiproduct installations

1.Introduction   The EMA has approved on the 20th of November 2014, the new guide “Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities”. Once approved, this guide will have to […]

Blog Alberto Carazo Pharmaceutical support 0 comentarios 23 - 10 - 14

Dedicated facilities versus multiproduct facilities

In pharmaceutical manufacturing plants there is always the doubt related to when it is necessary to have a dedicated facility or when it is possible to manufacture in a same area different products specially when some of them are steroids, sexual hormones, corticoids, cytostatics, high potency, prostaglandins, …
FDA and EU required dedicated facilities for betalactamics antibiotics and when manipulating pathogenic alive organisms. For the rest of products the segregation and dedicated facilities should be required when the physical and procedural controls cannot demonstrate the capacity to keep under acceptable control limits the risk of cross contamination

Blog Alberto Carazo Sin categoría 0 comentarios 10 - 09 - 14

New concept in the design of sterile manufacturing areas

  1. Introduction: Primary packaging suppliers are reporting investments in order to increase the use of primary materials pre-sterilized, “Ready to Use” (RU). These materials open up new possibilities and opportunities in the design of sterile manufacturing areas. 2. What’s […]

Blog Alberto Carazo Clean rooms 0 comentarios 4 - 08 - 14

HAPI (High Potent Active Ingredient) Manufacturing Dressing Room

In the pharmaceutical sector there is a clear tendency to develop and manufacture high potent products, currently they represent  35% of the global market share and 50% of products under development (Class 3 and 4 Safebridge classification). New areas or […]