# CVM GFI #126 BACPAC I-Intermediates in Drug Substance Synthesis Bulk Actives Postapproval Changes: Chemistry, Manufacturing, and Controls Documentation - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/cvm-gfi-126-bacpac-i-intermediates-in-drug-substance-synthesis-bulk-actives-postapproval-changes-chemistry-manufacturing-and-controls-documentation/b81e8e56-c453-49c6-880d-62c5dc8c17d6

> FDA guidance document: CVM GFI #126 BACPAC I-Intermediates in Drug Substance Synthesis Bulk Actives Postapproval Changes: Chemistry, Manufacturing, and Controls Documentation. Issue date: June 01, 2006. Get complete insights and analysis.

---

## Details

- Title: CVM GFI #126 BACPAC I-Intermediates in Drug Substance Synthesis Bulk Actives Postapproval Changes: Chemistry, Manufacturing, and Controls Documentation
- Communication Type: Guidance Document
- Product Type: veterinary
- Office Name: Center for Veterinary Medicine
- Office URL: /offices/center-for-veterinary-medicine/7e30a309-56e4-4e7a-8b8b-e07674bb07b4
- Issue Date: 2006-06-01
- Last Changed: 2021-07-27
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2021-D-0610">FDA-2021-D-0610</a>

## Related Documents

- [CVM GFI #204 Active Controls in Studies to Demonstrate Effectiveness of a New Animal Drug for use in Companion Animals](https://www.globalkeysolutions.net/guidances/guidance-document/cvm-gfi-204-active-controls-in-studies-to-demonstrate-effectiveness-of-a-new-animal-drug-for-use-in-companion-animals/d9bc3b93-f53a-4229-921d-feae8cf01c81)
- [CVM GFI #92 (VICH GL10(R)) Impurities In New Veterinary Drug Substances](https://www.globalkeysolutions.net/guidances/guidance-document/cvm-gfi-92-vich-gl10r-impurities-in-new-veterinary-drug-substances/9b1e0fd4-5cd0-40ca-b252-b3c6e3e53a37)
- [CVM GFI #156 Comparability Protocols - Chemistry, Manufacturing, and Controls Information for New Animal Drugs](https://www.globalkeysolutions.net/guidances/guidance-document/cvm-gfi-156-comparability-protocols-chemistry-manufacturing-and-controls-information-for-new-animal-drugs/3b46eda7-635e-4041-aff7-92c21da620bb)
