DB32/T 4556-2023 English Version, DB32/T 4556-2023 Guidelines for investigating out-of-specification test results for pharmaceutical production (English Version)

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DB32/T 4556-2023 Guidelines for investigating out-of-specification test results for pharmaceutical production (English Version)
Standard No.:	DB32/T 4556-2023	Status:	valid remind me the status change Email:
Language:	English	File Format:	PDF
Word Count:	7500 words	Price(USD):	225.0 remind me the price change Email:
Implemented on:	2023-10-22	Delivery:	via email in 1~3 business day

Standard No.:	DB32/T 4556-2023
English Name:	Guidelines for investigating out-of-specification test results for pharmaceutical production
Chinese Name:	药品生产检验结果超标调查指南
Chinese Classification:	C00 Standardization and quality management
Professional Classification:	DB Provincial Standard
ICS Classification:	11.120.99 11.120.99 Other standards related to pharmaceutics 11.120.99
Issued by:	Jiangsu Adminstration of Market Regulation
Issued on:	2023-09-22
Implemented on:	2023-10-22
Status:	valid
Language:	English
File Format:	PDF
Word Count:	7500 words
Price(USD):	225.0
Delivery:	via email in 1~3 business day

Standard

DB32/T 4556-2023 Guidelines for investigating out-of-specification test results for pharmaceutical production (English Version)
Standard No.	DB32/T 4556-2023
Status	valid
Language	English
File Format	PDF
Word Count	7500 words
Price(USD)	225.0
Implemented on	2023-10-22
Delivery	via email in 1~3 business day

Detail of DB32/T 4556-2023

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Introduction of DB32/T 4556-2023

本文件提供了药品生产检验结果超出标准时对超标数据的调查流程和方法。
本文件适用于超出质量标准的实验室检验项目，包括物料（原料药、辅料、药品包装材料）、中间产品、成品及稳定性考察样品等的检验。
本文件不适用于分析方法验证、检验员培训，新购进仪器和系统验证（如计算机化系统）期间产生的数据，过程分析技术（PAT）产生的数据，微生物相关检验项目。

Contents of DB32/T 4556-2023

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Keywords:
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