Good Manufacturing Practices Sample Clauses
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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. Products shall be manufactured and tested by Seller in accordance with all applicable U.S. laws and United States Food and Drug Administration (FDA) regulations, including but not limited to the FDA's current Good Manufacturing Practice regulations in effect at the time of such manufacture or testing. Seller shall notify Buyer of any FDA inspection of its production facilities used to manufacture any products and shall furnish Buyer with copies of any Form 483 report and Establishment. Inspection Reports to the extent that they apply to any product.
Good Manufacturing Practices. “Good Manufacturing Practices” shall mean, 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. 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. All employees on each site are committed to following Good Manufacturing Practices covering safety, quality, hygiene, housekeeping, cleanliness, appearance, operating procedures, responsibility, identification and maintenance.
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. (a) Access shall ensure that all Devices are designed and manufactured in material compliance with (i) FDA’s Good Manufacturing Practices, [***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. which are codified in the Quality System Regulation (“QSR”) set forth in 21 C.F.R. Part 820, (ii) the Quality Agreement and (iii) the Supply Agreement.
(b) AMAG shall ensure that it conducts any QSR-related activities in substantial compliance with FDA’s requirements, as necessary. Without limiting the generality of the foregoing, such activities may include, among others, incoming inspections, warehousing and storage, Device handling and maintenance of distribution records. All Device Returns which are to be quarantined and marked in such a fashion as to not be confused with inventory for sale, and warehousing in a manner that prevents damage to Devices.
Good Manufacturing Practices. Products will be manufactured and packaged by Supplier in accordance with current Good Manufacturing Practices (“cGMP”).
Good Manufacturing Practices. EDT shall ensure that Contract Manufacturer and any other contractors/affiliates shall manufacture, store and prepare all Product and related raw materials for shipping in accordance with the cGMPs, in a facility to be agreed upon by EDT and SM. EDT may not change manufacturing of the Product to an alternate facility without first obtaining SM’s written approval.
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.