Definitions of GMP and GLP Sample Clauses

Definitions of GMP and GLP. 1.1 Definition of GMP For the purposes of this document, Good Manufacturing Practice (GMP) will mean Good Manufacturing Practices and General Biological Products Standards as promulgated under the US Federal Food and Drug and Cosmetic Act at 21CFR, (chapters 210, 211, 600 and 610) and the Commission of the European Communities Rules Governing Medicinal Products in the European Community (Volume IV : Good Manufacturing Practice for Medicinal Products, 1992) as the same may be amended or re-enacted from time to time. Lonza's operational quality standards are defined in internal GMP policy documents and are based on Lonza's interpretation of the GMP legislation for bulk clinical grade Biologicals. Additional product-specific development, documentation and validation work may be required to support regulatory applications to conduct clinical trials, or market a product.
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