Buenas Practicas de Manufacturas (BPM) de Productos Radiofarmacéuticos (Good Manufacturing Practices (GMP) for Radiopharmaceutical Products) (20 pages, in Spanish)
The notified Technical Standard establishes guidelines, the main aim of which are to set out the basic specific requirements for the manufacturing of radiopharmaceutical products, and to supplement, in an Annex, the requirements established for sterile and non-sterile pharmaceutical products in Technical Standard No. 127 of 2013 of the Ministry of Health (MINSAL) on Good Manufacturing Practices (GMP) for the pharmaceutical industry, published pursuant to MINSAL Exempt Decree No. 159 of 11 April 2013, which updates Technical Standard No. 127 adopted in 2012.
In view of the above, establishments manufacturing sterile radiopharmaceutical products must comply with the notified Standard, as well as with Annex No. 2 of Technical Standard No. 127, which updates and amends the Standard. This Technical Standard shall apply to the manufacturing procedures used by pharmaceutical laboratories producing radiopharmaceutical products and research institutions developing radiopharmaceuticals.