# Q5C Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/q5c-quality-of-biotechnological-products-stability-testing-of-biotechnologicalbiological-products/371b51f2-ae87-4ef8-aa87-6a82dbe5a1eb

> FDA guidance document: Q5C Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products. Issue date: July 01, 1996. Get complete insights and analysis.

---

## Details

- Title: Q5C Quality of Biotechnological Products: Stability Testing of 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: 1996-07-01
- Last Changed: 2019-04-08

## Related Documents

- [Q5B Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products](https://www.globalkeysolutions.net/guidances/guidance-document/q5b-quality-of-biotechnological-products-analysis-of-the-expression-construct-in-cells-used-for-production-of-r-dna-derived-protein-products/245613c2-f488-4d8f-a017-e16fbd69e2ed)
- [S1A The Need for Long-term Rodent Carcinogenicity Studies of Pharmaceuticals](https://www.globalkeysolutions.net/guidances/guidance-document/s1a-the-need-for-long-term-rodent-carcinogenicity-studies-of-pharmaceuticals/47727f71-5bb8-4ab4-b93a-c974612755da)
- [Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived Products:  Guidance for Industry](https://www.globalkeysolutions.net/guidances/guidance-document/content-and-format-of-investigational-new-drug-applications-inds-for-phase-1-studies-of-drugs-including-well-characterized-therapeutic-biotechnology-derived-products-guidance-for-industry/ecc5878c-4062-49df-90cc-6ac91b3adb4c)