new construction cell therapy manufacturing site
TRANSCRIPT
Operational Readiness Overview❑ Pharmaceutical Technical Solutions, Inc. Overview
❑ Integrated Project Schedule (IPS) Operational Readiness activities
❑ Commissioning Plan (Utilities/ HVAC)
❑ Validation Master Plan (GMP Manufacturing Facility/ QC Labs/
Warehouse)
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❑ Utilities/ HVAC Equipment Operational
Readiness
❑ Utilities/ HVAC Equipment
❑ Commissioning Utilities/ HVAC Equipment
❑ GMP Manufacturing Facility Readiness
❑ GMP Site Operational Readiness
❑ GMP Manufacturing Facility (Equipment/
HVAC/ Utilities/ Process)
❑ GMP Quality Control and R&D Laboratories
(Equipment/ Utilities/ Method Transfer)
❑ GMP Warehouse (Equipment/ HVAC/ Utilities)
GMP Manufacturing Facility Operational Readiness Integrated Project Schedule (IPS)
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Operational Readiness IPS Activities:
❑ Construction Project Schedule Dates
❑ Commissioning Plan Activities
❑ Validation Plan Activities
❑ Equipment Receipt Verification (ERV)
❑ Asset Induction (CMMS)
❑ Develop Operational Procedures/ SOP’s
❑ Pre-Mechanical Completion (PMC)
❑ Mechanical Completion (MC)
❑ Turn Over Package (TOP)
❑ Calibration
❑ SAT/ Startup/ HVAC Balancing
❑ HEPA Certification/ Smoke Studies
❑ Ozonation of GMP Manufacturing Facility
❑ IOQ/ OQ/ PQ/ EMPQ - Development/ Execution
❑ Training - Development/ Execution
Utility/ HVAC Equipment Commissioning Activities
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Pre-Commissioning Activities:
❑ Develop Commissioning Plan
❑ Update Integrated Project Schedule
❑ Asset Induction (CMMS)
❑ Equipment Receipt Verification
❑ Equipment Spare Parts Inventory
❑ Operations/ Maintenance Manual Library (Cloud)
❑ Develop Operational Procedures
❑ Pre-Mechanical Completion (PMC)
❑ Calibration Execution
Commissioning Activities:
❑ TOP Utilities/ HVAC
❑ Drawing Management
❑ Approve PM Job Plans
❑ Mechanical Completion (MC)
❑ Execute OEM SAT
❑ Training Execution
❑ Generate/ Approve Commissioning Reports (Engineering Approved)
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Utility Equipment:
❑ Boilers
❑ Chillers
❑ Air Compressors
❑ HVAC Hot Water Package
❑ Fire System
❑ Industrial Water
❑ Potable (H&C)
❑ Ln2
❑ C02
❑ Central Utility Control System
❑ Electrical
❑ Emergency Power Generators
❑ UPS
HVAC Equipment:
❑ Air Handlers
❑ HVAC Hot Water/ Re-heat Coil System
❑ Chilled Water System
❑ Compressed Air System
❑ Terminal HEPA Filter Housings
❑ HEPA Filter Certification Installation/ Smoke Studies
❑ Rough/ Final HVAC Balancing
❑ Building Management System❑ Static/ Differential Pressure instrument
calibration and SAT
❑ Environmental Monitoring System❑ Device calibration/ setup and SAT
Utility/ HVAC Equipment Tracked in IPS
GMP Manufacturing Process Operational Readiness IPS Activities
Manufacturing Validation & Supporting Activities:
❑ Process SOP’s & Forms/ Process Flow Drawings
❑ Manufacturing Batch Record/ Forms
❑ Execute “Make a Batch”
❑ Critical Quality Attribute Assessment
❑ Training
❑ Surface Cleaning & Sanitization
❑ Ozonation of GMP Manufacturing Facility
❑ EMPQ
❑ PQ- Temperature Mapping
❑ PQ- Process Media Simulations (BSC Smoke Studies)
❑ Shakedown/ Cycle Development Runs
❑ Engineering Run/ GMP Runs
❑ Process Validation (PPQ Runs)
❑ Process Control Monitoring
❑ QC Testing/ Sampling Plan
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GMP Manufacturing FacilityValidation Master Plan Activities
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Validation Activities:
❑ Design Qualification
❑ Functional Design Specification
❑ Author/ Approve Validation Plan
❑ Establish/ Maintain IPS
❑ Equipment Receipt Verification
❑ Equipment Spare Parts Inventory
❑ Maintenance Manual Library
❑ Asset Induction (CMMS)/ Master Equipment/ System List
❑ Calibration Execution
❑ Update or Author SOP’s/ Forms & Batch Records/ Forms
❑ IOQ Execution
❑ PQ- Temperature Studies/ EMPQ
❑ PQ- Process Medial Simulation
❑ Shake Down, Engineering, GMP & PPQ Runs
MFG Equipment Readiness:
❑ TOP-Equipment
❑ Approve SOP’s/ Forms/ MBR
❑ Execute Training
❑ TOP-Construction
❑ Mechanical Completion (MC)
❑ Execute Validation
❑ Generate/ Approve Validation Reports
MFG Documentation:
❑ Operational/ Instrument SOP’s
❑ MFG Batch Records/ Forms
❑ Training Module Development/ Execution
MFG Materials:
❑ Consumables
❑ Raw Materials
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Process Equipment:
❑ Incubators
❑ Class II Biological Safety Cabinets
❑ Centrifuges
❑ Microscopes
❑ pH Meters
❑ Thermometers
❑ Dry Block Heaters
❑ Water Baths
❑ Filling Equipment
❑ Inspection/ Labeling
❑ Control Rate Freezer
❑ Liquid Nitrogen Storage Units
❑ Refrigerators
❑ Freezers
❑ Cold Room
❑ Freezer Room
Process Control System:
❑ BMS (Differential Pressure Monitoring/ Trending Alarming)
❑ Environmental Monitoring System
❑ MFG Door Interlock System
❑ Clock System
GMP Manufacturing Facility Equipment Tracked in IPS
GMP Manufacturing FacilityFacilities Operational Readiness IPS Activities
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Pre-Commissioning Activities:
❑ Author/ Approve Commissioning Plan
❑ Update Integrated Project Schedule
❑ MFG Facility Rooms Induction (CMMS)
❑ Equipment/ System PM Job Plan Development and Spare Parts Inventory
❑ Develop Operational Procedures
❑ Facilities Pre-Mechanical Completion (PMC)
Commissioning Activities:
❑ Turn Over Package (TOP)
❑ Approve PM Job Plans
❑ Mechanical Completion (MC)
❑ Training Execution
❑ Generate/ Approve Commissioning Reports (Engineering Approved)
GMP QC and R&D Laboratories Equipment Operational Readiness
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Pre-Validation Activities:
❑ Author/ Approve Validation Plan
❑ Establish/ Maintain IPS
❑ IOQ Execution
❑ Spare Parts Inventory
❑ Maintenance Manual Library
❑ Asset Induction (CMMS)
❑ Pre-Mechanical Completion (PMC)
❑ Calibration Execution
❑ Training Module Development
❑ Update or Author SOP’s
Equipment Readiness:
❑ TOP-Equipment
❑ Approve SOP’s
❑ Execute Training
❑ TOP-Construction
❑ Mechanical Check Out (MCO)
❑ Execute Validation
❑ Generate/ Approve Validation
Reports
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Lab Equipment:
❑ Incubators
❑ Class II Biological Safety Cabinets
❑ Centrifuges
❑ Microscopes
❑ pH Meters
❑ Thermometers
❑ Plate Washer
❑ Water Baths
❑ Multi Label Reader
❑ Cell Counter
❑ Milli-Q or WFI System
❑ Liquid Nitrogen Storage Units
❑ Refrigerators
❑ Freezers
❑ Cold Room
❑ Freezer Room
Process Control System:
❑ BMS (Differential Pressure Monitoring/ Trending Alarming)
❑ Environmental Monitoring System
❑ MFG Door Interlock System
❑ Clock System
GMP QC and R&D Laboratories Equipment Tracked in IPS
GMP QC and R&D Laboratories Operational Readiness
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GMP Documentation:
❑ Operational/ Instrument SOP’s
❑ QC Forms
❑ Training
R&D Documentation:
❑ Operational/ Instrument SOP’s
❑ Bio-Analytical Forms
❑ Training
R&D Commissioning:
❑ Equipment SAT
❑ Freezer/ Refrigerator/ Incubators Temperature Calibration
GMP Validation:
❑ Equipment IOQ’s
❑ Freezer/ Refrigerator/ Incubators Temperature Studies
GMP and R&D Lab Materials:
❑ Lab Consumables
❑ Lab Reagents
GMP Warehouse Utility/ HVAC Equipment Commissioning Activities
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Pre-Commissioning Activities:
❑ Author/ Approve Commissioning Plan
❑ Update Integrated Project Schedule
❑ Asset Induction (CMMS)
❑ Equipment Receipt Verification
❑ Equipment Spare Parts Inventory
❑ Operations/ Maintenance Manual Library (Cloud)
❑ Develop Operational Procedures
❑ Pre-Mechanical Completion (PMC)
❑ Calibration Execution
Commissioning Activities:
❑ Turn Over Package (TOP) Utilities/ HVAC
❑ Drawing Management
❑ Approve PM Job Plans
❑ Mechanical Completion (MC)
❑ Execute OEM SAT
❑ Training Execution
❑ Generate/ Approve Commissioning Reports (Engineering Approved)
GMP Warehouse Equipment Readiness
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Pre-Validation Activities:
❑ Author/ Approve Validation Plan
❑ Establish/ Maintain IPS
❑ IOQ Execution
❑ Spare Parts Inventory
❑ Maintenance Manual Library
❑ Asset Induction (CMMS)
❑ Pre-Mechanical Completion (PMC)
❑ Calibration Execution
❑ Training Module Development
❑ Update or Author SOP’s
Equipment Readiness:
❑ TOP-Equipment
❑ Approve SOP’s
❑ Execute Training
❑ TOP-Construction
❑ Mechanical Check Out (MCO)
❑ Execute Validation
❑ Generate/ Approve Validation
Reports
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Warehouse Equipment:
❑ Class II Biological Safety Cabinets
❑ Refrigerators
❑ Freezers
❑ Cold Room
❑ Freezer Room
Process Control System:
❑ BMS (Differential Pressure Monitoring/ Trending Alarming)
❑ Environmental Monitoring System
❑ MFG Door Interlock System
❑ Clock System
GMP Warehouse Equipment Tracked in IPS