Quality by design- newer technique for pharmaceutical product development

Intelligent Pharmacy Pub Date : 2024-02-01 DOI:10.1016/j.ipha.2023.10.004

Anwar Khan , Kamran Javed Naquvi , Md Faheem Haider , Mohsin Ali Khan

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Abstract

Regulatory bodies are nowadays concerned with pharmaceutical drug products' safety, efficacy, and quality. Quality is the priority of all regulatory bodies, it is a high priority for the triple P factor (patient, pharmacist, and physician). It links pharmaceutical industries and regulatory authorities for designing, manufacturing, and consistently delivering safe and efficient products.

It mainly focuses on fabricating and designing formulations and manufacturing processes to ensure predefined product quality. It is based on the ICH Guidelines Q8 for pharmaceutical development, Q9 for quality risk management, and Q10 for pharmaceutical quality systems. Some of the important effective elements of QbD are to define the target profile that what is the requirement of the pharmacist, physician, and patient (TPP-QTPP) then measuring the criticality for achieving that target (CQA) and analyzing the risk assessment of variables associated with materials and controlling processes to produce consistent quality over time. The objective of this review is to discuss the concept of Quality by Design and describe its application in pharmaceutical product development.

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质量源于设计--医药产品开发的新技术

如今，监管机构关注的是药品的安全性、有效性和质量。质量是所有监管机构的首要任务，也是三P因素（患者、药剂师和医生）的重中之重。它将制药业和监管机构联系在一起，以设计、生产和持续提供安全高效的产品。它主要侧重于配方和生产工艺的制造和设计，以确保预定的产品质量。它以 ICH 准则 Q8（药品开发）、Q9（质量风险管理）和 Q10（药品质量体系）为基础。QbD 的一些重要有效元素包括：定义药剂师、医生和患者要求的目标概况（TPP-QTPP），然后测量实现该目标的关键性（CQA），分析与材料和控制过程相关的变量的风险评估，以产生长期一致的质量。本综述旨在讨论 "质量源于设计 "的概念，并介绍其在医药产品开发中的应用。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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Intelligent Pharmacy

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