Manufacturing intermediate
Peptide Drug Reprocessing: Comprehensive Peptide Reference
Procedures and controls for reprocessing and reworking peptide drug products during manufacturing. This peptide or oligopeptide is studied for its biological...
By Encyclopeptide Editorial | 1 min read
reprocessing rework manufacturing quality GMP
Overview
Reprocessing and reworking are controlled procedures for recovering peptide drug products that do not meet specifications.
Definitions
Reprocessing
- Incorporating failed batches into subsequent batches
- Following established procedures
Reworking
- Processing failed batch through additional steps
- Requires regulatory approval
Controls Required
- Deviation investigation
- Root cause analysis
- Risk assessment
- Quality approval
- Documentation
Chemical Identity
| Property | Value |
|---|---|
| Name | Peptide Drug Reprocessing |
| Category | Manufacturing |
References
- Encyclopeptide Database. “Peptide Drug Reprocessing” monograph. encyclopeptide.com.
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