Cleaning validation of Chinese materia medica preparation manufactured in shared production line
10.7501/j.issn.0253-2670.2016.10.030
- Author:
Shou-Bin WANG
1
Author Information
1. Certification Center of TianJin Market and Quality Supervision Administration
- Publication Type:Journal Article
- Keywords:
Chinese materia medica preparation;
Cleaning validation;
Marker component;
Shared production line;
UV-full wavelength scan
- From:
Chinese Traditional and Herbal Drugs
2016;47(10):1815-1819
- CountryChina
- Language:Chinese
-
Abstract:
This paper illustrates the company's cleaning validation of many varieties of Chinese materia medica (CMM) preparation manufatured in the same production line by real case from four aspects such as selection of target product, confirmation of marker, validation of acceptance criteria, and analytical methods. It is a scientific, rational, and economic validation strategy to use CMM preparation extract or the whole extract powder as marker components for validation and determination of the marker components using UV-full wavelength scan method.
