Manufacturing Deviations Sample Clauses

Manufacturing Deviations. Any deviation from the process during manufacture, packaging, testing, storage, or release of the Product shall be documented by Flextronics and approved by Flextronics quality assurance and appropriate area management. Flextronics will notify Alimera in writing on a timely basis if any problems are discovered that may impact Product previously shipped in order to reasonably allow Alimera to meet regulatory reporting guidelines. A list of all deviations from the process during manufacture, packaging, testing, storage, or release of the Product will be provided to Alimera with any release documentation package provided to Alimera. A copy of any final investigation report will be reviewed with Alimera and included in the Product release documentation package provided to Alimera.
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Manufacturing Deviations. Manufacturing deviations are documented and investigated based on Corixa controlled documents on the handling of deviations. Deviations are consistently evaluated for any impact on the quality, purity, safety, and/or potency of the product. Deviation and Observation Reporting System Forms (DORS) provide details of any deviation or observation of unusual manufacturing conditions (also provides details of any deviation/observation outside of manufacturing area. and includes documentation of all assessments, investigations, decisions and subsequent corrective actions. The DORS Event number is referenced on the batch record documentation. The original document is stored in the associated DORS Event file. Out of Specification Reports (OOS) provide details of any failure of the product to meet defined specifications and includes documentation of all assessments, investigations, decisions and subsequent corrective actions. Environmental Deviation Reports (EDR) provide details of any failure of the production environment to meet defined specifications and includes documentation of all assessments, investigations, decisions and subsequent corrective actions. None of these documents (DORS, OOS, EDR) become permanent parts of the associated batch record Corixa standard operating procedures prohibit the release of materials until all deviations have been resolved. Corixa QA is to decide the final status of the materials following appropriate investigations and assessments. GSKBio QA requires full transparency around any individual deviation affecting MPL- product, testing or shipment. LOT RELEASE TESTING Final products are tested according to current release specifications as listed on part number specification sheets for each material requiring testing. Quality Control personnel analyze the material, document the test results on the Quality Control Analysis Report form, and attach all hard data to the form. Once testing is completed, the Quality Control Analysis Report form and all hard data are reviewed by the Quality Control Manager. The testing data is forwarded to the Quality Assurance Manager for final accept/reject decisions based upon testing results as well as review of all manufacturing documentation including deviations from procedures. If the final product meets all release specifications and has been manufactured according to required procedures with no significant deviations, a notification of release is provided to Central Supply by Quality Assurance to...
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Manufacturing Deviations. Any deviation from the process during manufacture, and any confirmed Product OOS result shall be documented by DPI. DPI will notify AMAG within [***] business hours if any problems are [***] 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. discovered that may impact Product batches previously shipped in order to assure that regulatory reporting guidelines may be met. Deviations will require review and approval by AMAG and DPI Quality Assurance personnel. A list of all investigations and all deviations will be provided to AMAG with the Release Documentation package provided to AMAG. A copy of any final investigation report will be included in the Release Documentation package provided to AMAG. DPI will notify AMAG in the event that a Product or customer provided material will be rejected.
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Manufacturing Deviations. Any deviation from the process during manufacture, and any OOS result shall be documented by DSM and approved by DSM Quality Assurance and appropriate area management. DSM will notify XANODYNE on a timely basis if any problems are discovered that may impact Product batches previously shipped in order to assure that regulatory reporting guidelines may be met. A list of all investigations will be provided to XANODYNE with the Release Documentation package provided to XANODYNE. A copy of any final investigation report will be reviewed with XANODYNE and included in the Release Documentation package provided to XANODYNE. DSM will notify XANODYNE in the event that a Product or customer provided material will be rejected. This communication will be accompanied by a completed investigation with regard to the failure and include an evaluation of effect of the failure on other batches.
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Related to Manufacturing Deviations

  • Product Specifications The Company agrees that all Products sold to Xxxx hereunder shall conform to the respective specifications set forth on Schedule A or to such other specifications as are from time to time agreed upon by the Parties.

  • Manufacturing Services Jabil will manufacture the Product in accordance with the Specifications and any applicable Build Schedules. Jabil will reply to each proposed Build Schedule that is submitted in accordance with the terms of this Agreement by notifying Company of its acceptance or rejection within three (3) business days of receipt of any proposed Build Schedule. In the event of Jabil’s rejection of a proposed Build Schedule, Jabil’s notice of rejection will specify the basis for such rejection. When requested by Company, and subject to appropriate fee and cost adjustments, Jabil will provide Additional Services for existing or future Product manufactured by Jabil. Company shall be solely responsible for the sufficiency and adequacy of the Specifications [***].

  • Manufacturing Intrexon shall have the option and, in the event it so elects, shall use Diligent Efforts, to perform any manufacturing activities in connection with the Aquaculture Program that relate to the Intrexon Materials, including through the use of a suitable Third Party contract manufacturer. To the extent that Intrexon so elects, Intrexon may request that AquaBounty and Intrexon establish and execute a separate manufacturing and supply agreement, which agreement will establish and govern the production, quality assurance, and regulatory activities associated with manufacture of Intrexon Materials. Except as provided in Section 4.1, any manufacturing undertaken by Intrexon pursuant to the preceding sentence shall be performed in exchange for cash payments equal to Intrexon’s Fully Loaded Cost in connection with such manufacturing, on terms to be negotiated by the Parties in good faith. In the event that Intrexon does not manufacture Intrexon Materials or bulk quantities of other components of AquaBounty Products, then Intrexon shall provide to AquaBounty or a contract manufacturer selected by AquaBounty and approved by Intrexon (such approval not to be unreasonably withheld) all Information Controlled by Intrexon that is (a) related to the manufacturing of such Intrexon Materials or bulk qualities of other components of AquaBounty Products for use in the Field and (b) reasonably necessary to enable AquaBounty or such contract manufacturer (as appropriate) for the sole purpose of manufacturing such Intrexon Materials or bulk quantities of other components of AquaBounty Products. The costs and expenses incurred by Intrexon in carrying out such transfer shall be borne by Intrexon. Any manufacturing Information transferred hereunder to AquaBounty or its contract manufacturer shall not be further transferred to any Third Party, including any Product Sublicensee, or any AquaBounty Affiliate without the prior written consent of Intrexon; provided, however, that Intrexon shall not unreasonably withhold such consent if necessary to permit AquaBounty to switch manufacturers.

  • Quality Specifications SANMINA-SCI shall comply with the quality specifications set forth in its Quality Manual, incorporated by reference herein, a copy of which is available from SANMINA-SCI upon request.

  • Technical Specifications Each Bloom System is an integrated system comprised of a fuel cell stack assembly and associated balance of plant components that converts a fuel into electricity using electrochemical means that (i) has a Nameplate Capacity of at least 0.5 kilowatts of electricity using an electrochemical process and (ii) has an electricity-only generation efficiency greater than thirty percent (30%).

  • API A. Reliant shall supply to Cardinal Health for Manufacturing and Packaging, at Reliant’s sole cost, the API and applicable reference standards in quantities sufficient to meet Reliant’s requirements for each Product as further set forth in Article 4. Prior to delivery of any of the API or reference standard to Cardinal Health for Manufacturing and Packaging, Reliant shall provide to Cardinal Health a copy of the API Material Safety Data Sheet (“MSDS”), as amended, and any subsequent revisions thereto. Reliant shall supply the API, reference standards, and Certificate of Analysis FOB the Facility no later than thirty (30) days before the scheduled Manufacture Date upon which such API will be used by Cardinal Health. Upon receipt of the API, Cardinal Health shall conduct identification testing of the API. Cardinal Health shall use the API solely and exclusively for Manufacturing and Packaging under this Agreement. The maximum volume of API that Reliant supplies to Cardinal Health shall not exceed the amount reflected in the Firm Commitment and the next six (6) months of the Rolling Forecast.

  • Manufacturing Rights Manufacturing Rights will be governed by Attachment 6.

  • Commercialization Reports After the First Commercial Sale of a Licensed Product anywhere in the Territory, LICENSEE shall submit to Cornell semi-annual reports on or before each February 28 and August 31 of each year. Each report shall cover LICENSEE’s (and each Affiliate’s and Sublicensee’s) most recently completed calendar half-year and shall show:

  • Project Plan Based on the Project Specifications, Omnicare CR has provided a description of services to be performed for Sponsor’s “A multi-center, randomized, double-blind, double-dummy, vehicle-controlled sequential cohort study to determine the safety of PEP005 0.025% and 0.05% topical gel in patients with actinic keratoses” (hereinafter “the Project”) and associated costs. Changes made in the Project scope, at any time during the Project, will result in a corresponding adjustment to the Project costs.

  • Manufacturing Costs In the event of termination by Merck pursuant to Section 6.2, 6.3 or 6.6 above, Merck shall be entitled to [*****] (as defined herein) incurred by Merck for its Compound Delivered for the Study. [*****]

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