Good Manufacturing Practices Sample Clauses

Good Manufacturing Practices. (GMP’s). [The United States has clari- fied its interpretation that under the MRA, paragraph (c)(1) of this section has to be understood as the U.S. defini- tion and paragraph (c)(2) as the EC def- inition.] (1) GMP’s mean the requirements found in the legislations, regulations, and administrative provisions for methods to be used in, and the facili- ties or controls to be used for, the man- ufacturing, processing, packing, and/or holding of a drug to assure that such drug meets the requirements as to safe- ty, and has the identity and strength, and meets the quality and purity char- acteristics that it purports or is rep- resented to possess. (2) GMP’s are that part of quality as- surance which ensures that products are consistently produced and con- trolled to quality standards. For the purpose of this subpart, GMP’s include, therefore, the system whereby the manufacturer receives the specifica- tions of the product and/or process from the marketing authorization/ product authorization or license holder or applicant and ensures the product is made in compliance with its specifica- tions (qualified person certification in the EC).

Good Manufacturing Practices. “Good Manufacturing Practices” or “GMP” means, as applicable, those current good manufacturing practices related to the manufacture of pharmaceutical products and any precursors thereto set forth in Legal Requirements, including (a) the FDCA and 21 C.F.R. Parts 210-211, (b) guidelines and regulations of standard compilations in Directive (EU) 2017/1572 of 15 September 2017 supplementing Directive 2001/83/EC of the European Parliament and of the Council as regards the principles and guidelines of good manufacturing practice for medicinal products for human use, and (c) other foreign equivalents of the foregoing, in each case, as same may be amended from time to time.

Good Manufacturing Practices. QUALITY SYSTEMS REGULATIONS. MacroPore shall be responsible for compliance with present and future applicable statutes, laws, ordinances and regulations of national, federal, state and local governments now or hereafter in effect relating to the [design,] manufacture and/or quality of Developed Products. Without limitation of the foregoing, MacroPore represents and warrants to Medtronic that all Developed Products sold and delivered to Medtronic under this Agreement will have been manufactured in accordance with all applicable requirements. MacroPore shall cause Medtronic's regulatory personnel to be provided with reasonable access from time to time to the facilities and records of MacroPore for the purpose of confirming MacroPore's compliance with this Section 4.2.

Good Manufacturing Practices. All employees on the site are committed to following Good Manufacturing Practices covering safety, quality, hygiene, housekeeping, cleanliness, appearance, procedures, responsibility, identification and maintenance.

Good Manufacturing Practices. Products will be manufactured and packaged by Supplier in accordance with current Good Manufacturing Practices (“cGMP”).

Good Manufacturing Practices. Affymetrix represents and warrants that it will at all times under this Agreement use commercially reasonable efforts to comply with U.S. FDA good manufacturing practices then in effect and conform to all other applicable statutes and regulations. BCI may, from time to time, upon not less than five (5) days prior written notice to Affymetrix inspect the Affymetrix facilities where the Products are being manufactured and/or stored.

Good Manufacturing Practices. The Technical Agreement contains provisions relating to GMPs. If Allos’ failure to comply with applicable Laws causes a Supply Interruption, Section 4 of this Agreement will apply.

Good Manufacturing Practices. Bioniche represents that it shall observe and adhere to the requirements of the current EU Guide to Good Manufacturing Practice for Medicinal Products for Human Use, including supplementary recommendations issued by the Commission of the European Communities (cGMPs) and current US cGMPs. All terms defined in the cGMPs shall have the same meaning when used in this document. Bioniche represents and warrants that all processes and equipment used in the manufacture of the Product shall have been validated or are in the process of being validated in accordance with the cGMPs and current US cGMPs. The reference to other regulatory requirements will be agreed between the two parties.

Good Manufacturing Practices. Products will be manufactured and packaged by Gland or by agreed upon third-party manufacturers in accordance with current Good Manufacturing Practices (“cGMP”) and the applicable approved DMF and NDA or ANDA.