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Which Batch Size for Validation and Stability Studies? Process validation for a drug product must be done with commercial scale batches, says Siegfried Schmitt, vice president, Technical at Parexel.
- Source :
- BioPharm International; May2022, Vol. 35 Issue 5, p50-49, 2p
- Publication Year :
- 2022
-
Abstract
- The article provides an answer to the question on whether splitting a commercialize batch of a new drug into sub batches for process validation and stability data requirement purposes is compliant with U.S. and European Union pharmaceutical industry regulations.
- Subjects :
- RESEARCH methodology
MARKETING
Subjects
Details
- Language :
- English
- ISSN :
- 1542166X
- Volume :
- 35
- Issue :
- 5
- Database :
- Complementary Index
- Journal :
- BioPharm International
- Publication Type :
- Periodical
- Accession number :
- 156697220