학술논문
Stage 2 Process Validation: Regulatory Expectations and Approaches to Determine and Justify the Number of PPQ Batches.
Document Type
Article
Source
Subject
*Product quality
*Drug supply & demand
Biopharmaceutics
Drug factories
Guidelines
*
Language
ISSN
1543-2521
Abstract
The article focuses on the regulatory expectations and approaches approaches that can be used to determine and justify the number of Process performance qualification (PPQ) batches. Topics discussed include rise in demand for biotechnology-derived drugs, quality of biopharmaceutical products and guidelines introduced by the U.S. Food and Drug Administration (FDA)