质量保证导论述评

Divyashree Kantilal Patil, Divyani Rajendra Patil, Sunila A. Pati
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摘要

质量保证(QA)是一种管理技术,用于对产品、服务或结果满足质量要求并适合使用提供充分的信心。每个监测程序或评估都必须努力生成精确、可靠和充分用于指定目的的数据。数据质量目标是用于创建一个将不确定性水平保持在允许范围和可接受水平的系统的定性和定量标准。质素保证可提升公众及资助机构的信心。未经证实的观察结果在得到证实之前不应使用。健全的药品质量保证体系确保产品的有效性和安全性。遵循良好生产规范(GMP)和制定全面的检查政策有助于药品制造商生产最高质量的产品,避免声誉受损事件。产品质量评审(PQR)是一种机制,用于确保对药品质量体系(PQS)捕获的数据进行趋势评审。该工具可以支持持续改进的环境。设计PQRs的目的是确定和实施所需改进的建议。质量控制和质量保证工作都是为了确保药物是正确制造的,安全使用的,以及有预期的效果。如果没有质量管理的这两个功能,制药组织将难以实现其产出的一致性。质量保证(QA)是确定产品或服务是否满足规定要求的任何系统过程。QA建立并维护开发或制造可靠产品的既定要求。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
A Review on Introduction to Quality Assurance
Quality assurance (QA) is the management technique used to provide adequate confidence that a product, service, or result will satisfy requirements for quality and be fit for use. Each monitoring program or assessment must strive to generate data that is precise, dependable, and sufficient for the specified purpose. Data quality objectives are qualitative and quantitative standards that are used to create a system that will keep the level of uncertainty within permitted boundaries and at an acceptable level. Quality assurance will boost public and funding body confidence. Unconfirmed observations should not be used until they can be verified. Robust pharmaceutical quality assurance system ensures that products are effective and safe. Following good manufacturing practices (GMP) and enacting comprehensive inspection policies help drug manufacturers produce the highest quality products and avoid reputation-damaging incidents. Product Quality Review (PQR) is a mechanism to ensure that data captured by the Pharmaceutical Quality System (PQS) is reviewed for trends. This tool can support a continuous improvement environment. PQRs are designed for the purpose of identifying and implementing recommendations for required improvements. Quality control and quality assurance jobs are all about ensuring the medication has been manufactured correctly and is safe to use, as well as having its desired effect. Without these two functions of quality management, a pharmaceutical organisation would struggle to achieve consistency in its output. Quality assurance (QA) is any systematic process of determining whether a product or service meets specified requirements. QA establishes and maintains set requirements for developing or manufacturing reliable products.
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