Manufacturing Deviations Clause Samples
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.
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...
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.
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.