New Construction Cell Therapy Manufacturing Site

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New Construction Cell Therapy Manufacturing Site

Operational Readiness Overview

Steven Sandoval

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


❑ Equipment Receipt Verification

❑ Equipment Spare Parts Inventory

❑ Operations/ Maintenance Manual Library (Cloud)

❑ Develop Operational Procedures


❑ Calibration Execution

Commissioning Activities:

❑ TOP Utilities/ HVAC

❑ Drawing Management

❑ Approve PM Job Plans


❑ 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



❑ Maintenance Manual Library

❑ Asset Induction (CMMS)/ Master Equipment/ System List


❑ 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


❑ 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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❑ Author/ Approve Commissioning Plan


❑ MFG Facility Rooms Induction (CMMS)

❑ Equipment/ System PM Job Plan Development and Spare Parts Inventory


❑ Facilities Pre-Mechanical Completion (PMC)


❑ Turn Over Package (TOP)





GMP QC and R&D Laboratories Equipment Operational Readiness

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Pre-Validation Activities:



❑ IOQ Execution

❑ Spare Parts Inventory





❑ Training Module Development

❑ Update or Author SOP’s

Equipment Readiness:

❑ TOP-Equipment

❑ Approve SOP’s



❑ Mechanical Check Out (MCO)


❑ Generate/ Approve Validation

Reports

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Lab Equipment:

❑ Incubators


❑ 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





❑ 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:


❑ QC Forms

❑ Training

R&D Documentation:


❑ 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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❑ Author/ Approve Commissioning Plan





❑ Operations/ Maintenance Manual Library (Cloud)





❑ Turn Over Package (TOP) Utilities/ HVAC

❑ Drawing Management



❑ Execute OEM SAT



GMP Warehouse Equipment Readiness

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Pre-Validation Activities:



❑ IOQ Execution

❑ Spare Parts Inventory





❑ Training Module Development

❑ Update or Author SOP’s

Equipment Readiness:

❑ TOP-Equipment

❑ Approve SOP’s



❑ Mechanical Check Out (MCO)


❑ Generate/ Approve Validation

Reports

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Warehouse Equipment:


❑ Refrigerators

❑ Freezers

❑ Cold Room

❑ Freezer Room





❑ Clock System

GMP Warehouse Equipment Tracked in IPS

New Construction Cell Therapy Manufacturing Site

Documents

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