# Current Good Manufacturing Practice for Phase 1 Investigational Drugs:  Guidance for Industry - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/current-good-manufacturing-practice-for-phase-1-investigational-drugs-guidance-for-industry/179f8504-7c99-4bec-826e-e67ad9ce1f79

> FDA guidance document: Current Good Manufacturing Practice for Phase 1 Investigational Drugs:  Guidance for Industry. Issue date: July 14, 2008. Get complete insights and analysis.

---

## Details

- Title: Current Good Manufacturing Practice for Phase 1 Investigational Drugs:  Guidance for Industry
- Communication Type: Guidance Document
- Product Type: biologics
- Office Name: Center for Drug Evaluation and Research
- Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c
- Issue Date: 2008-07-14
- Last Changed: 2023-09-29
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2005-D-0157">FDA-2005-D-0157</a>

## Related Documents

- [E2E Pharmacovigilance Planning](https://www.globalkeysolutions.net/guidances/guidance-document/e2e-pharmacovigilance-planning/89ea2b55-7e7d-4a99-9e7f-9aac73abf09b)
- [Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations](https://www.globalkeysolutions.net/guidances/guidance-document/quality-systems-approach-to-pharmaceutical-current-good-manufacturing-practice-regulations/9ed0e9b2-d08c-4cb7-b5fd-6cd0b3699b31)
- [Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice:  Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/sterile-drug-products-produced-by-aseptic-processing-current-good-manufacturing-practice-guidance-for-industry/0404765b-fedd-4d75-91f6-24f8781614ad)
