Good Manufacturing Practices Sample Clauses

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

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. 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. 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.

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. Where Seller provides goods or services for Buyer to manufacture medicinal products that require compliance with the principles and guidelines of current good manufacturing practices (“cGMP”) it is the responsibility of Seller to satisfy the following additional requirements. A. Seller personnel shall have appropriate education, training and experience, training shall be documented and records shall be available to Buyer upon request; B. Seller shall follow generally recognized good documentation practices for cGMP documentation; C. Seller shall perform services in accordance with written standard operating procedures; X. Xxxxxx shall record and investigate deviations and out-of-specification results; X. Xxxxxx shall notify Buyer within two (2) business days of discovery of a nonconformance that where the integrity of the service or good is compromised; X. Xxxxxx shall provide information to Buyer in response to qualification questionnaires provided by Xxxxx and if requested, shall allow access to its premises and to relevant documentation to allow Buyer to assess Seller’s compliance with the terms of this [Order] and cGMP and will provide prompt written responses to any findings; G. Seller shall maintain records of source manufacturer(s) and chain-of-custody; H. Seller shall notify Buyer of relevant changes impacting the goods or services provided, e.g. changes in premises where services are performed or goods are produced, key equipment used, processes or specifications. Seller shall provide a minimum of ninety (90) days’ advance notice to enable Buyer to evaluate the potential impact of the change; I. Seller shall retain records relating to the goods and/or services provided to Buyer for a minimum of 7 years or for such longer period as may be required by applicable laws and regulations; J. Seller shall only utilize original equipment manufacturer parts when performing preventative or corrective maintenance on Buyer equipment; K. Seller shall utilize current NIST traceable, or equivalent, standards to perform calibration for Buyer and when calibrating equipment to be used for services to be provided to Buyer; X. Xxxxxx shall provide all paperwork related to performance of calibration to Buyer on the same day that work is completed for work performed at a Buyer site; M. Seller shall utilize standard operating procedures and status labels provided by Buyer for all work performed at a Buyer site unless otherwise agreed in writing; N. Seller shall document ...