制药行业的清洁验证

Poonam Khalate, B. Chaudhari, V. Redasani
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引用次数: 0

摘要

在制药工业中存在污染、交叉污染、微生物污染、药物与其他有效成分掺假或与其他材料如原料、灰尘、润滑剂、中间体和空气中颗粒污染的可能性清洁验证验证清洁程序对去除赋形剂、产品残留、降解产物和清洁剂的有效性。清洗验证提高了给定药品生产和设备中清洗的效力和可靠性。清洗验证是质量保证的重要组成部分。因此,在制药行业,验证清洁程序对于确保药品批次的安全性、有效性和质量至关重要。本综述的目的是为制药行业的清洁验证提供信息,以提供更好的客户服务和产品质量。本文将讨论清洁验证在制药领域的相关性,并将根据监管指南进行讨论
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Cleaning Validation in Pharmaceutical Industry
In pharmaceutical industries there is possibilities of contamination, cross contamination, microbial contamination, adulteration of drug with other active ingredient or contamination with other material like raw material, dust, lubricant, intermediates and air born particle.1 Cleaning validation validate the effectiveness of cleaning procedure for removal of excipient, product residue, degradation product and cleaning agent. Cleaning validation improves the potency and reliability of cleaning in given pharmaceutical production and equipment. The cleaning validation is essential part of the quality assurance. As a result, validating cleaning procedures is critical in the pharmaceutical sector to ensure the safety, efficacy, and quality of drug batches. The purpose of this review is to provide information about cleaning validation in pharmaceutical industry to provide better customer care and quality of product. This article will discuss the relevance of cleaning validation in the pharmaceutical sector, and it will do so in accordance with regulatory guidelines.2,3
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