Regulatory document
Process validation for the manufacture of biotechnology-derived active substances and data…
EMA · Guidance · EU · Apr 30, 2014
Key facts
| Title | Process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission - Scientific guideline |
|---|---|
| Issuer | European Medicines Agency |
| Source | EMA |
| Document type | Guidance |
| Country or region | EU |
| Date | Apr 30, 2014 |
| Document | ema.europa.eu |
| Issuer website | ema.europa.eu |
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