FDA Good Manufacturing Practices definition
FDA Good Manufacturing Practices means the standards set forth in 21 C.F.R. Parts 210, 211 and 600 (and any foreign equivalents).
FDA Good Manufacturing Practices means the standards set forth in 21 C.F.R. Part 820 (and any foreign equivalent) and FDA’s implementing guidance documents (and any foreign equivalent).
FDA Good Manufacturing Practices means the applicable requirements and standards set forth in the Food, Drug, and Cosmetic Act (“FDCA”) and its implementing regulations (for example, for pharmaceuticals being used in Phase 2 or 3 studies, and commercial pharmaceuticals, 21 C.F.R. Parts 210 and 211) and relevant FDA guidance documents (for example, for pharmaceuticals in Phase 1, FDA guidance entitled “CGMP for Phase 1 Investigational Drugs”.
Examples of FDA Good Manufacturing Practices in a sentence
Keep all Inventory in good and marketable condition, free from material defects and otherwise keep all Inventory in material compliance with all applicable FDA Good Manufacturing Practices.
More Definitions of FDA Good Manufacturing Practices
FDA Good Manufacturing Practices means as defined in 21 Code of Federal Regulations Part 820.
FDA Good Manufacturing Practices means the requirements set forth in 21 C.F.R. Part 820.
FDA Good Manufacturing Practices means the current good manufacturing practices requirements as set forth in 21 C.F.R. Part 110, Part 111, Part 210, and/or Part 211, all FDA Guidance documents and policies implementing such regulations, and all Canadian or other foreign equivalents thereto.
FDA Good Manufacturing Practices means the applicable requirements and standards set forth in the Food, Drug, and Cosmetic Act and its implementing regulations (for example, for pharmaceuticals being used in Phase 2 or 3 studies, and commercial pharmaceuticals, 21 C.F.R. Parts 210 and 211) and relevant FDA guidance documents (for example, for pharmaceuticals in Phase 1, FDA guidance entitled “CGMP for Phase 1 Investigational Drugs”).
FDA Good Manufacturing Practices means the standards set forth in 21 C.F.R. Parts 210, 211 and 600 (and any foreign equivalents). “FDA Laws” means all applicable statutes, rules, regulations and orders administered or issued by FDA (and any foreign equivalent). “FDCA” is defined in Section 13.2 “Federal Funds Rate” means for any day, the rate per annum equal to the weighted average of the rates on overnight Federal funds transactions with members of the Federal Reserve System, as published on the next succeeding Business Day by the Federal Reserve Bank of New York, or, if such rate is not so published for any day which is a Business Day, the average of the quotations for such day on such transactions received by Agent from three Federal funds brokers of recognized standing selected -89-
FDA Good Manufacturing Practices means the standards set forth in 21 C.F.R. Part 820 (and any foreign equivalents), and as interpreted through applicable guidance documents by FDA (and foreign equivalents). “FDA Laws” means all applicable statutes (including the FDCA and the Public Health Service Act (42 U.S.C. § 262 through § 263) (the “PHSA”), rules and regulations implemented, administered, or enforced by the FDA and any United States state and foreign equivalents, and as interpreted through applicable guidance documents by the FDA (and United States state and foreign equivalents). “FDCA” is defined in Section 4.19(b).
FDA Good Manufacturing Practices means the standards set forth in 21 C.F.R. Parts 210, 211 and 600 (and any foreign equivalents). “FDA Laws” means all applicable statutes, rules, regulations and orders administered or issued by FDA (and any foreign equivalent). “FDCA” is defined in Section 13.2 “Federal Funds Rate” means for any day, the rate per annum equal to the weighted average of the rates on overnight Federal funds transactions with members of the Federal Reserve System, as published on the next succeeding Business Day by the Federal Reserve Bank of New York, or, if such rate is not so published for any day which is a Business Day, the average of the quotations for such day on such transactions received by Agent from three Federal funds brokers of recognized standing selected -89-