# An Adequate Pharmaceutical Quality System for Personalized Preparation
## 2 Personalized Preparation Quality: Definitions and Legislation  
There have been innumerable studies into quality management for industrially manufactured medicine production. A slew of legislations, regulations, and guidelines have been pursued by national and international organizations. Two fine examples are the Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use (from the European Commission [8]) and the Good Manufacturing Practices (GMPs), created by the Food and Drug Administration (FDA) and disseminated internationally [9]. The specifications of raw materials, definitions, description of controls, and much more information are collected in the various pharmacopoias--European (E.P) [10], United States Pharmacopoia (USP), and others--and, likewise, the legislation that regulates them. In the European Pharmacopoia, there is no specific section on magistral compounding. Nor are there any monographs on the finished product. By contrast, the USP does have specific sections (795 and 797) [11; 12]. It contains monographs about compounded preparations with specifications that can be taken as a point of reference. The regulations, norms, and debate on personalized preparation quality can be considered a field of study that is underdeveloped. Many of the regulations established for industrially manufactured medicines are not directly applicable to personalized preparations. One of the aims of this work is to review and discuss the legislation on personalized preparation quality. Due to globalization in the manufacture and marketing of industrially manufactured medicines, there is an international harmonization of the regulatory authorities and industry representatives of the largest world powers (the United States, Canada, Europe, and Japan), that aims to square the technical and scientific requirements for the registration and authorization of medicines [13]. As pharmacy compounding for personalized preparations is for a specific patient and pathology, the unification of criteria is not needed in response to commercial criteria; therefore, there has been no harmonization process in this field. However, these are not the only criteria that should be considered. Rather a more relevant common criterion is the accessibility of medicines and the safety of patients around the world. There are references to the unification of criteria in some regions, such as the proposed Latin American Formulary, fostered by the Latin American Medication Authorities network (EAMI). This is a response to the existing need in most Latin American countries to establish quality criteria for the production of magistral and official formulas. Thus, this organization has articulated a joint document that envisions the minimum requirements to be met by pharmacy offices and hospital pharmacy services producing magistral and official formulas [14]. At a European level, Directive 2001/83/EC [8] defines a magistral formula as a medicine prepared in a pharmacy from a medical prescription intended for a certain patient; and an official formula as medicines prepared in a pharmacy from the indications of a pharmacopeia, intended to be dispensed directly to patients served by said pharmacy. These magistral and official formulas comprise what is referred to in this article as \"personalized preparations\", which is a term that is both more current and more precisely defines their use and function. This directive thus exempts personalized preparations from compliance with manufacturing and marketing authorization. The Guide to Good Practices in the preparation of medicinal products in health establishments--created by the Pharmaceutical Inspection Convention (PIC) [15]--is another European publication worthy of note. This guide offers guidance on Good Practices in the preparation of medicines for direct supply to patients that are produced by healthcare establishments.