# Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Annex - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/q12-technical-and-regulatory-considerations-for-pharmaceutical-product-lifecycle-management-annex/5379f689-7e71-423b-b00d-e8c8654bbd0b

> FDA guidance document: Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Annex. Issue date: May 11, 2021. Get complete insights and analysis.

---

## Details

- Title: Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Annex
- 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: 2021-05-11
- Last Changed: 2021-10-28
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2018-D-1609">FDA-2018-D-1609</a>

## Related Documents

- [Bispecific Antibody Development Programs Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/bispecific-antibody-development-programs-guidance-for-industry/16d40dbb-63de-4441-b656-7949b4a1018d)
- [Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Guidance for Industry:  Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/q12-technical-and-regulatory-considerations-for-pharmaceutical-product-lifecycle-management-guidance-for-industry-guidance-for-industry/3d2c4a48-664c-46f3-8af1-d21c9b7858a3)
- [S5(R3) Detection of Reproductive and Developmental Toxicity for Human Pharmaceuticals :  Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/s5r3-detection-of-reproductive-and-developmental-toxicity-for-human-pharmaceuticals-guidance-for-industry/b68debd9-c581-404c-b7fd-963716474af6)