Regulatory document
Considerations for Pre-specifying the Change Categories for Manufacturing Process…
PMDA · Information · Japan
Key facts
| Title | Considerations for Pre-specifying the Change Categories for Manufacturing Process Parameters Identified as Established Conditions for Drug Products (Chemical Products) (Early Consideration) |
|---|---|
| Issuer | Pharmaceuticals and Medical Devices Agency |
| Source | PMDA |
| Document type | Information |
| Country or region | Japan |
| Document | pmda.go.jp |
| Issuer website | pmda.go.jp |
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