Parametric Release of Aseptic Drug Products
- VernacularTitle:浅析无菌药品的参数放行
- Author:
Minfei GU
- Publication Type:Journal Article
- Keywords:
Aseptic;
Drug;
GMP;
Parametric release
- From:
China Pharmacy
1991;0(04):-
- CountryChina
- Language:Chinese
-
Abstract:
OBJECTIVE:To provide references for the improving of the quality control level for aseptic drug products.METHODS:The advantages of parametric release of aseptic drug products and its enforcement were elucidated by comparing it with the traditional quality control technique and referring to parametric release guideline of developed countries.RESULTS & CONCLUSIONS:Parametric release could provide high-level quality assurance for aseptic drug products.It is inevitable for parametric release to substitute the traditional quality control technique.
