Shakers
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100.06.37_Installation,_Operation_and_Maintenance_of_the_Vi-CELL_Cell_Viability_Analyzer.pdf
•
100.08.01_Specification,_Purchasing--Purchase,_Commissioning--Equipment,_Instruments,_Software--GxP_Use.pdf
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100.08.02 Visual Inspection of Production Equipment
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100.08.03 Cleaning Check-Out for Equipment Prior to First-Time Use
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100.08.05 Commissioning of Facilities and Equipment for GMP Use.pdf
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100.09.36 Sampling of Manufacturing Bioreactors
•
100.09.46 Operation of the Terumo Sterile Tube Welder
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100.09.59 Standardization and Operation of Conductivity Meter for
Manufacturing
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100.09.65 Maintenance of Fermentors and Control Skids
•
100.12.01 Operation and Maintenance of the Fyrite CO2 Analyzer
•
100.14.03 Operation of Laminar Air Flow Work Stations
•
100.15.01 Operation and Maintenance of XOMA Quality Control High Pressure Liquid
Chromatography (HPLC) Systems
Schedule 6.2 - 21
•
100.15.07_Operation_and_Maintenance_of_the_Agilent_1100_and 1200
High-Pressure_Liquid_Chromatography_(HPLC)_Systems.pdf
•
100.15.09_Operation_and_Maintenance_of_the_Beckman_Coulter_Proteome_Lab_PA_800_Protein_Characterization_System.pdf
•
100.15.10_HPLC_Column_Conditioning_Procedure_for_New_Quality_Control_Analytical_Columns.pdf
•
100.16.14_Operation_of_the_Forma_Orbital_Shake.pdf
•
100.16.15_Operation_and_Maintenance_of_the_MaxQ_2000_Orbital_Shaker.pdf
•
100.17.10_Operation,_Calibration_and_Maintenance_of_the_Fisher_Scientific_Accumet_XL20_pH_Meter.pdf
•
100.23.03 Operation of Power Supplies
•
100.28.16 Operation, Maintenance, and Calibration of the Shimadzu PharmaSpec
UV-1700 UV Spectrophotometer
•
100.28.18_Operation_and_Maintenance_of_the_Shimadzu_Model_UV-1800_UV_Spectrophotometer--dated.pdf
•
100.28.19_Operation,_Maintenance,_Calibration_of_Spectramax_M2_Microplate_Reader.pdf
•
100.30.11_Preparation_of_Disposable_TFF_Cassettes.pdf
•
100.31.03_Operation_and
_Calibration_of_Electronic_Balances_in_Bioanalytical_Development.pdf
•
100.33.07 Operation and Maintenance of Controlled Temperature Chambers
•
100.34.09 Vapor Testing
•
100.37.39 Operation and Maintenance of Quality Control Water Baths, Ovens, and
Furnaces
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100.37.50 Analytical Equipment Calibration and Preventative Maintenance
•
100.37.63 Operation and Maintenance of the Cell and Analytical Development (AD)
GxP Water Baths
•
100.37.64_Operation_of_the_Nova_Biomedical_Bioprofile_400_Analyzer.pdf
•
100.37.80_Operation_and_Maintenance_of_Water_Baths_in_Bioanalytical_Development.pdf
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105.01.01_Master_Schedule_Maintenance.pdf
•
105.01.02_GLP_Organizational_Chart.pdf
•
105.01.03_GLP_Management_Roles_and_Responsibilities.pdf
•
105.01.04_Definitions_of_GLP_Terminology.pdf
•
105.01.05 QAU GLP Protocol Review and Copy Maintenance
•
105.01.07_Preparation_of_a_GLP_Phase_Study_Report_by_Preclinical_Research.pdf
•
105.01.09_Overview_of_Procedures_Followed_which_Support_GLP_Nonclinical_Laboratory_Studies.pdf
•
105.02.00_GLP_QAU_Phase_and_Report_Inspections.pdf
•
105.02.01_QAU_Roles_and_Responsibilites.pdf
•
105.02.02 Test Article Fabrication and Characterization for GLP Use
•
105.03.01_Glossary_of_GLP_Terminology_Used_in_Bioanalytical_Development.pdf
•
105.03.05_Determination_of_Bulk_Drug_Substance_and Drug Product Homogenity.pdf
•
105.03.06_Bioanalytical_Development_Assay_Transfer.pdf
Schedule 6.2 - 22
•
105.03.07_Operation_and_Cleaning_of_Laminar_Air_Flow_Work_Stations in
Bioanalytical Development.pdf
•
105.03.13_Maintenance_of_Instrument_Records_in_Bioanalytical_Development.pdf
•
105.03.15_Chain_of_Custody_Data_Handling_in_Bioanalytical_Development.pdf
•
105.03.16_Incurred_Sample_Reproducibility_Evaluation_of_GLP_Study_Samples_for_Pharmacokinetic_Analysis.pdf
•
105.03.37_Laboratory_Housekeeping_and_Maintenance_Checklist_Procedure_in_Bioanalytical_Development.pdf
•
105.03.38_Installation,_Operation,_and_Maintenance_of_the_Vi-Cell_XR_Viability_Analyzer_in_Bioanalytical_Development.pdf
•
105.03.39_Instructions_Clinical_Pharmacokinetic,_Immunogenicity_Study_Sample_Collection_Processing,
Shipping to Bio Dev.pdf
•
105.03.44_WinNonlin_Pharmacokinetic_Analysis_System.pdf
•
105.03.45_Data_Storage_for_GLP_Studies_in_the_Pharmacokinetic_Department.pdf
•
105.03.46_Bioanalysis,_Samples_and_Data_Handling_and_Data_Release_for_Double-Masked_(Double-Blinded)_Clinical_Trials.pdf
•
105.04.00_GLP_Study_Sample_Long Term Storage_in_Bioanalytical_Development.pdf
•
105.04.01_GLP_Archivist_and_Archiving.doc.pdf
•
105.06.00_GLP_Compliance_Assessment_Procedure_for_GLP_Nonclinical_Laboratory_Studies.pdf
•
105.06.01_Roles_and_Responsibilities_for_Sponsor_Representatives_who_Support_GLP_Nonclinical_Laboratory_Studies.pdf
•
105.06.03_Roles_and_Responsibilities_for_Prinicpal_Investigators_who_Support_GLP_Nonclinical_Laboratory_Studies.pdf
•
110.01.01_Pharmaceutical_Worker_Hygiene_and_Health_Requirements.pdf
•
120.01.05 Functions and Responsibilities of the Quality Unit.
•
120.01.08_Quality_Risk_Management
•
120.02.01 Inspection Policy
•
120.03.02 Evaluating Invalid, Unexpected and Out of Specification and Out of
Trend Test Results.
•
120.03.07 Deviation Reporting and Resolution
•
120.03.08 Technology Transfer
•
120.03.09 Data Recording Rules
•
120.03.11 Expiration Date Policy
•
120.03.12 Outside Contractors Policy and Procedure
•
120.03.16 Document Change Control Procedure
•
120.03.18 Planned Change Request
•
120.03.19 Corrective And Preventive Action (CAPA) Program
•
120.03.20 QA Guidance on Regulatory Department Approval of DCRs and ECRs
•
120.03.30 XOMA Policy on Manufacturing Process and Analytical Method Technology
Transfer to Outside Parties.pdf
•
120.04.02_Product_Specification_File_Requirements.pdf
•
120.05.01 Vendor Qualification - Certificate of Analysis
•
120.05.02_Quality_Agreement_Procedure.pdf
Schedule 6.2 - 23
•
120.06.02 Vendor Audit Program
•
120.06.03 Internal and Third Party Audit Program
•
120.06.08 Qualifying Contract Testing Laboratories
•
130.01.02 Assigning Numbers to Controlled Documents
•
130.01.04 Master Signature List
•
130.02.04 Reporting Results - Use of Significant Figures and Rounding Rules
•
130.03.03 Laboratory Notebook Issuance and Archiving
•
130.04.02 Assigning Validation Document Numbers and Archiving Validation
Documents
•
130.05.15 Labeling Practices Within Quality Control
•
130.06.01 Submission of Files to the Document Control Archives
•
130.06.03 Security and Policy of the Document Control Archives
•
130.07.01 Storing Documents