# Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/q5e-comparability-of-biotechnologicalbiological-products-subject-to-changes-in-their-manufacturing-process/9a44cd22-b665-4ffa-bb74-136ea2893c92

> FDA guidance document: Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process. Issue date: June 30, 2005. Get complete insights and analysis.

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## Details

- Title: Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process
- 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: 2005-06-30
- Last Changed: 2020-04-14
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2004-D-0440">FDA-2004-D-0440</a>

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