# Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/q6b-specifications-test-procedures-and-acceptance-criteria-for-biotechnologicalbiological-products/740f7ae1-889d-4f37-a427-0155ae5957c6

> FDA guidance document: Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products. Issue date: August 18, 1999. Get complete insights and analysis.

---

## Details

- Title: Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products
- Communication Type: Guidance Document
- Product Type: drugs
- Office Name: Center for Drug Evaluation and Research
- Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c
- Issue Date: 1999-08-18
- Last Changed: 2020-04-14
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-1998-D-0003">FDA-1998-D-0003</a>

## Related Documents

- [M4S: The CTD -- Safety](https://www.globalkeysolutions.net/guidances/guidance-document/m4s-the-ctd-safety/3d4fa9c6-5f48-4dc5-b89c-00dd678bc870)
- [IND Meetings for Human Drugs and Biologics Chemistry, Manufacturing, and Controls Information:  Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/ind-meetings-for-human-drugs-and-biologics-chemistry-manufacturing-and-controls-information-guidance-for-industry/d36eac77-5bcf-4737-b484-0bdcaf6b5c77)
- [Container Closure Systems for Packaging Human Drugs and Biologics -- Questions and Answers:  Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/container-closure-systems-for-packaging-human-drugs-and-biologics-questions-and-answers-guidance-for-industry/65c49013-89c0-4092-8da3-edd988fe933a)
