Product Controls. 4.5.1 Master Batch Record (X) X 4.5.2 Reprocessing and Rework (X) X 4.5.3 Personnel Training X 4.6 Packaging, Labeling and Printed Materials 4.6.1 Master Batch Packaging Records (X) X 4.6.2 Content of Printed Material and Artwork X 4.6.3 Test Methods and Method Validation (X) X 4.7 Exception Reports (Deviations / Investigations) 4.7.1 Manufacturing Instruction Deviations X 4.7.2 Packaging Instructions Deviations X 4.7.3 Notification of Deviations X Quality Agreement QG01-05-T001-01 Page4of18
Appears in 2 contracts
Samples: Manufacturing Services Agreement (Horizon Therapeutics Public LTD Co), Manufacturing Services Agreement (Horizon Pharma PLC)
Product Controls. 4.5.1 1.5.1 Master Batch Record (X) X 4.5.2 Reprocessing 1.5.2 Re-process and Rework (X) X 4.5.3 re-work N/A N/A 1.5.3 Personnel Training X 4.6 1.6. Packaging, Labeling Labelling and Printed Materials 4.6.1 1.6.1 Master Batch Packaging Records (X) X 4.6.2 Content of 1.6.2 Printed Material and Artwork X 4.6.3 Test Methods and Method Validation (X) X 4.7 1.7. Exception Reports (Deviations / Investigations) 4.7.1 1.7.1 Manufacturing Instruction Deviations (X) X 4.7.2 Packaging Instructions 1.7.2 General Deviations (X) X 4.7.3 1.7.3 Notification of Deviations X Quality Agreement QG01-05-T001-01 Page4of18X
Appears in 1 contract
Samples: Commercial Supply Agreement (Supernus Pharmaceuticals Inc)
Product Controls. 4.5.1 Master Batch Record (X) X 4.5.2 Reprocessing and Rework (X) X 4.5.3 Personnel Training X 4.6 Packaging, Labeling and Printed Materials 4.6.1 Master Batch Packaging Records (X) X 4.6.2 Content of Printed Material and Artwork X 4.6.3 Test Methods and Method Validation (X) 4.6.3 Packaging Components Specifications and Validation X (X) 4.7 Exception Reports (Deviations / Investigations) 4.7.1 Manufacturing Instruction Deviations (X) X 4.7.2 Packaging Instructions Deviations (X) X 4.7.3 Notification of Deviations (X) X Quality Agreement QG01-05-T001-01 Page4of184.8 Release of Product 4.8.1 Test Methods and Specifications X 4.8.2 Batch Release to client (X) X 4.8.3 Certificate of Compliance X 4.8.4 Product Release to market X
Appears in 1 contract
Product Controls. 4.5.1 Master Batch Record (X) X 4.5.2 Reprocessing and Rework (X) X 4.5.3 Personnel Training X 4.6 Packaging, Labeling and Printed Materials 4.6.1 Master Batch Packaging Records (X) X 4.6.2 Content of Printed Material and Artwork X 4.6.3 Test Methods and Method Validation X (X) X 4.7 Exception Reports (Deviations / Investigations) 4.7.1 Manufacturing Instruction Deviations X 4.7.2 Packaging Instructions Deviations X 4.7.3 Notification of Deviations X Quality Agreement QG01-05-T001-01 Page4of18)
Appears in 1 contract
