Quality Control and Quality Assurance. Patheon will perform the quality control and quality assurance testing specified in the Quality Agreement. Batch review and release to Client will be the responsibility of Patheon’s quality assurance group. Patheon will perform its batch review and release responsibilities in accordance with Patheon’s standard operating procedures. Each time Patheon ships Products to Client, it will give Client a certificate of analysis and certificate of compliance, including deviations as specified by the Quality Agreement, including a statement that the batch has been manufactured and tested in accordance with Specifications and cGMPs. Client will have sole responsibility for the release of Products to the market. The form and style of batch documents, including, but not limited to, batch production records, lot packaging records, equipment set up control, operating parameters, and data printouts, raw material data, and laboratory notebooks are the exclusive property of Patheon. Specific Product related information contained in those batch documents is Client property.
Appears in 2 contracts
Samples: Master Manufacturing Services Agreement (Horizon Pharma, Inc.), Master Manufacturing Services Agreement (Horizon Pharma, Inc.)
Quality Control and Quality Assurance. Patheon will perform the quality control and quality assurance testing specified in the Quality AgreementAgreement and in accordance with the Specifications and cGMPs. Batch review and release to Client will be the responsibility of PatheonPatheon through it’s quality assurance group. Patheon will perform its batch Batch review and release responsibilities in accordance with Patheon’s standard operating procedures. Each time Patheon ships Products to Client, it will give Client a certificate of analysis and certificate of compliance, including deviations as specified by the Quality Agreement, compliance including a statement that the batch Batch has been manufactured and tested in accordance with Specifications cGMPs and cGMPsmeets the Specifications. Client will have sole responsibility for the release of Products to the market. The form and style of batch Batch documents, including, but not limited to, batch Batch production records, lot packaging records, equipment set up control, operating parameters, and data printouts, raw material data, and laboratory notebooks are the exclusive property of Patheon. Specific Product related information contained in those batch Batch documents is Client property.
Appears in 1 contract
Samples: Manufacturing Services Agreement (Acura Pharmaceuticals, Inc)
Quality Control and Quality Assurance. Patheon will perform the quality control and quality assurance testing specified in the Quality Agreement. Batch review and release to Client will be the responsibility of Patheon’s 's quality assurance group. Patheon will perform its batch review and release responsibilities in accordance with Patheon’s 's standard operating procedures. Each time Patheon ships Products to Client, it will give Client a certificate of analysis and certificate of compliance, including deviations as specified by the Quality Agreement, including a statement that the batch has been manufactured and tested in accordance with Specifications and cGMPs. Client will have sole responsibility for the release of Products to the market. The form and style of batch documents, including, but not limited to, batch production records, lot packaging records, equipment set up control, operating parameters, and data printouts, raw material data, and laboratory notebooks are the exclusive property of Patheon. Specific Product related information contained in those batch documents is Client property.
Appears in 1 contract
Samples: Master Manufacturing Services Agreement (Horizon Therapeutics Public LTD Co)