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This week, we will begin looking at some of the background information relating to the FDA Guidance Documents.
§ 10.115 Good Guidance Practices
This content is from the eCFR and is authoritative but unofficial.
| (a) | What are good guidance practices? Good guidance practices (GGPs) are the FDA's policies and procedures for developing, issuing, and using guidance documents. |
| (b) | What is a guidance document? |
| | (1) | Guidance documents are documents prepared for FDA staff, applicants/sponsors, and the public that describe the agency's interpretation of or policy on a regulatory issue. |
| | (2) | Guidance documents include, but are not limited to, documents that relate to: The design, production, labeling, promotion, manufacturing, and testing of regulated products; the processing, content, and evaluation or approval of submissions; and inspection and enforcement policies. |
| | (3) | Guidance documents do not include: Documents relating to internal FDA procedures, agency reports general information documents provided to consumers or health professionals, speeches, journal articles and editorials, media interviews, press materials, warning letters, memoranda of understanding, or other communications directed to individual persons or firms. |
Resource: eCFR :: 21 CFR 10.115 -- Good guidance practices.
Continued next week.
Loyd V. Allen, Jr., PhD, RPh
Editor-in-Chief
International Journal of Pharmaceutical Compounding
Remington: The Science and Practice of Pharmacy Twenty-second edition
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