FDA Good Manufacturing Practices definition

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 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 as defined in 21 Code of Federal Regulations Part 820.

Examples of FDA Good Manufacturing Practices in a sentence

• Early manufacturing demonstrates production of the substance in accordance with FDA Good Manufacturing Practices ("GMP") guidelines.

• Imagin will ensure that the i/Blue Imaging System will be in compliance with the requirements of the FDA, Good Manufacturing Practices (GMP), European medical device standard ISO 13485, and other international compliance requirements.

• Cost drivers related to mitigation elements for fish passage (e.g., grade control structures), water supply (e.g., water pumping or treatment), or habitat and infrastructure protection (e.g., bank stabilization), were associated with 118 dam removal projects.

• The discussion will include Bioterrorism Recordkeeping, FDA Good Manufacturing Practices (GMPs), sanitation standards, GRAS (Generally Regarded As Safe), bottling standards, and handling spent grains.

• Except as set forth on Schedule 4.6(o) of the Disclosure Letter, to the Knowledge of Parent, at the time of any shipment of any Product occurring prior to the applicable Closing Date, the units thereof so shipped complied in all material respects with their relevant specifications and were developed and manufactured in accordance in all material respects with current FDA Good Manufacturing Practices, FDA Good Clinical Practices, and FDA Good Laboratory Practices.

• The feed manufacturer will comply with FDA Good Manufacturing Practices.

• Therefore , those respondents educational background is very relatedto their position in those selected NGO’s and the researcher believes those respondents give relevant information for the study.✓ From a total of 86 respondents we have only 17 or 20% of respondents with a professional certification i.e. the majority of our respondents are not professionally certified (69 or 80% of respondents).

• Borrower shall cause its manufacturing and quality controls to conform to FDA Good Manufacturing Practices ("GMP") regulations and such other regulations applicable to Borrower with respect to advertising, labeling and reporting of adverse experiences with the use of any of Borrower's products, and those concerning recordkeeping, reporting, product testing, design, safety and labeling of products.

• The Product distributed or sold in the Territory at all times during the past five (5) years has been (i) manufactured in all material respects in accordance with current FDA Good Manufacturing Practices and (ii) if and to the extent the Product is required to be approved or cleared by the FDA pursuant to the FDCA, the Product has been so approved or cleared.

• Except as set forth on S chedule 4.6(q) of the Disclosure Letter, to the Knowledge of Borrower, at the time of any shipment of Product in the Territory occurring prior to the applicable Closing Date, the units thereof so shipped complied with their relevant specifications and were developed and manufactured in all material respects in accordance with current FDA Good Manufacturing Practices or applicable foreign equivalents.

More Definitions of FDA Good Manufacturing Practices

FDA Good Manufacturing Practices means the standards set forth in 21 C.F.R. Parts 210, 211 and 600.

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 requirements set forth in 21 C.F.R. Part 820.

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-

FDA Good Manufacturing Practices means the current good manufacturing practices requirements as set forth in the quality system regulation 21 C.F.R. Part 820 and the Canadian equivalent set forth in ISO 13485.