In-Process Testing. In-process testing shall be performed by Noven as required by Noven's standard operating procedures but at all times consistent with the applicable Product Application. Representative samples from each lot of a CombiPatch Product shall be tested by Noven for conformance with the requirements of the applicable Product Application prior to shipment of the full lot unless shipment prior to testing is agreed to in writing by Novogyne. Any lot which fails to conform to release standards shall be rejected. All laboratory testing failures must be investigated and documented by the testing laboratory. Product Specification failures resulting in batch rejections, in-process production and environmental control specification failures, and critical equipment operating parameter failures, must be fully investigated by Noven in a timely manner to determine the possible root cause, and necessary follow-up actions must be conducted promptly. Noven shall notify Novogyne, in writing, at the completion of Noven's investigation of each such failure and in the annual product review referred to in Article 3.21 hereof.
In-Process Testing. In-process materials were required to be tested for identity, strength, quality and purity as appropriate, and approved or rejected by the quality control unit during the production process� e.g. at commencement or completion of significant phases or after storage for long periods. 21 C.P.R. § 211.110(c) (2003).
In-Process Testing. During Processing, Targeted Genetics shall deliver to GenVec or a designee of GenVec samples of the in-process Batch in accordance with the Statement of Work or as otherwise directed by GenVec for purposes of in-process testing. If in-process testing reveals an out-of-Specification result, Targeted Genetics shall use its [*] efforts to fully investigate such out-of-Specification result within [*] following such testing, and shall provide such [*] to GenVec within [*] following the conclusion of such investigation as to the nature and cause of the out-of Specification result. * Confidential treatment requested.
In-Process Testing. OI shall perform the in-process Material inspection and testing procedures described on Appendix A to this Agreement. Before shipping any Material, OI shall supply NMT with a Certificate of Compliance with respect to such testing and the results thereof in the format specified on Appendix A. OI shall retain two (2) sample units of each manufacturing lot of Material shipped hereunder, for one (1) year after the Material expiration date listed Appendix A and, upon reasonable request of NMT, shall make such samples available for inspection and testing by NMT.
In-Process Testing. Bachem shall be responsible for ensuring that all required in-process testing is completed using suitable methods, when applicable, and documented. This will include environmental controls where required. Bachem shall also be responsible for defining appropriate tests and criteria.
In-Process Testing. Fleet is responsible for ensuring, and shall ensure, that all required in-process testing of Product is carried out and documented, and is in accordance with the requirements of Applicable Law, including, without limitation, those relating to cGMP.
In-Process Testing. While manufacturing the Product, SP will conduct the in process tests defined in the Master Batch Record for conformance to the corresponding specification:
