FDA guidance
Submission Documentation for Sterilization Process Validation in Applications for Human…
FDA guidance · Final · issued Nov 1, 1994
Key facts
| Title | Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products: Guidance for Industry |
|---|---|
| Status | Final |
| Issue date | Nov 1, 1994 |
| Center | Center for Drug Evaluation and Research |
| Issuing office | Center for Veterinary Medicine, Center for Drug Evaluation and Research |
| Communication type | Guidance Document |
| Regulated product | Animal & Veterinary, Drugs |
| Topics | Microbiology |
| Open for comment | No |
| Document on fda.gov | fda.gov |
At a glance
- 1–9 Product codes referenced
- 1–9 Recognized standards referenced
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA guidance documents
FDA guidance documents describe the agency's current thinking on regulatory topics. Drafts are issued for comment before a final version is published.
Source: U.S. Food and Drug Administration (FDA), Guidance Documents