# Q11 Development and Manufacture of Drug Substances--Questions and Answers (Chemical Entities and Biotechnological/Biological Entities) - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/q11-development-and-manufacture-of-drug-substances-questions-and-answers-chemical-entities-and-biotechnologicalbiological-entities/4bdf3485-1128-4a4c-bfdf-7ed5513ad725

> FDA guidance document: Q11 Development and Manufacture of Drug Substances--Questions and Answers (Chemical Entities and Biotechnological/Biological Entities). Issue date: February 26, 2018. Get complete insights and analysis.

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## Details

- Title: Q11 Development and Manufacture of Drug Substances--Questions and Answers (Chemical Entities and Biotechnological/Biological Entities)
- 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: 2018-02-26
- Last Changed: 2020-05-15
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2011-D-0436">FDA-2011-D-0436</a>

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