Diseño de un manual de requisitos básicos para el análisis y control de calidad de medicamentos

Abstract

This document establishes relevant information on how to apply the basic requirements in the analysis and quality control of drugs through protocols that are suggested by specific organizations such as the FDA (Food and Drug Administration) and ISO 9001:2000 (International Organization for Standardization) standards, this manual describes 12 basic fundamental requirements such as: sampling approved by the quality control department, validated methods of analysis, records, review of production documentation, failure investigations for all deviations, ingredients that comply with the marketing authorization, ingredients that have the purity, proper packaging, correct labeling, batch release by the authorized person, retention samples of raw materials and products, having one or more laboratories, with the necessary resources to ensure that all quality control decisions are executed reliably. The objective of this research work is to design a manual where adequate control can be carried out in the analysis and control of the pharmaceutical forms from their beginning to their commercialization.