Common use of Manufacturing Deviations Clause in Contracts

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 indicate release. Finished product is then removed from the Central Supply quarantine area to the finished goods area by Central Supply personnel. If the finished product does not meet release specifications, a procedure (SOP) is in place to track the disposition of the rejected material. A Material Rejection Report is completed by Quality Assurance and that report is circulated to representatives of Production, Adjuvant Development, Purchasing and Quality Control for signature. A copy of the completed Material Rejection Report indicating disposition of the rejected material, is provided to Accounting and the rejected material is disposed of appropriately. GSKBio will perform lot release testing upon receipt of MPL materials, according to GSKBio Quality Control Procedure 10026402 (Appendix 5). GSKBio will make their acceptance criteria and methods for determining acceptability available to Corixa. They will also advise Corixa of any changes in their requirements or methods. If the received bulk materials are found to not comply with the agreed specifications, GSK will notify Corixa immediately, advising Corixa of the batch number(s) and such details of the test failure as are available. After confirmation of the GSKBio testing result, Corixa shall retest samples from the same bulk retained. If Corixa finds that, based on the retested sample, the bulk does not comply with the specifications set forth in the Corixa material specifications, it will be treated as if no lot had been delivered and a replacement lot will be scheduled in accordance with the supply agreement. In the case that Corixa results and GSKBio results on the suspect lot do not match, and after a reasonable investigation on the reason for the opposing results Corixa, a mutually agreed third party shall continue testing of the suspect lot and decide on the questioned compliance with the set specifications. Corixa and GSKBio will share equally the costs associated with the third party testing including any costs associated with the necessary technology transfer. At the discretion of either party, this requirement may be waived and the opposing parties position accepted without any admission of fault.

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 indicate release. Finished product is then removed from the Central Supply quarantine area to the finished goods area by Central Supply personnel. If the finished product does not meet release specifications, a procedure (SOP) is in place to track the disposition of the rejected material. A Material Rejection Report is completed by Quality Assurance and that report is circulated to representatives of Production, Adjuvant Development, Purchasing and Quality Control for signature. A copy of the completed Material Rejection Report indicating disposition of the rejected material, is provided to Accounting and the rejected material is disposed of appropriately. GSKBio will perform lot release testing upon receipt of MPL materials, according to GSKBio Quality Control Procedure 10026402 (Appendix 5). GSKBio will make their acceptance criteria and methods for determining acceptability available to Corixa. They will also advise Corixa of any changes in their requirements or methods. If the received bulk materials are found to not comply with the agreed specifications, GSK will notify Corixa immediately, advising Corixa of the batch number(s) and such details of the test failure as are available. After confirmation of the GSKBio testing result, Corixa shall retest samples from the same bulk retained. If Corixa ▇▇▇▇▇▇ finds that, based on the retested sample, the bulk does not comply with the specifications set forth in the Corixa material specifications, it will be treated as if no lot had been delivered and a replacement lot will be scheduled in accordance with the supply agreement. In the case that Corixa results and GSKBio results on the suspect lot do not match, and after a reasonable investigation on the reason for the opposing results Corixa▇▇▇▇▇▇, a mutually agreed third party shall continue testing of the suspect lot and decide on the questioned compliance with the set specifications. Corixa and GSKBio will share equally the costs associated with the third party testing including any costs associated with the necessary technology transfer. At the discretion of either party, this requirement may be waived and the opposing parties position accepted without any admission of fault.