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8/12/2019 New Concepts in Pharma Facilities
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Pharmaceutical Facilities
Sanjit Singh LambaManaging Director
Eisai Knowledge Centre, Vizag, India
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INDUSTRY COMPARISON
2
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PHARMACEUTICAL MANUFACTURING IS AT A CROSSROADS
State of high variability ua y y nspec on
Low OEE , BRFT, OTIF
Batch manufacturing
High Inventory Less automated 90 % Pharma still paper based New product pipeline drying Less blockbusters Capacity utilization 30-40 %
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DESIGNER NEEDS TO KNOW
Regulatory agencies that will have jurisdiction over operation
Preparing URD , process and operational flow diagrams
How to design a facility conceptual design Corporate philosophies
Operating philosophies
Knowledge of manufacturing process flows
Material ersonnel and e ui ment flow atterns
Commissioning, qualification and validation approach
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HUMAN ERROR FACTOR
Can you really design a human error free facility?
Can we make procedures full proof for the peaks and valley of employee
intellect ?
Majority of lost batches was human error factor.
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RISK ASSESSMENT WORKSHOPS
What can go wrong?
How can it go wrong?
What is the potential harm?
What problems have we experienced in the past?
How did we manage it when it happened?
How can we stop it from happening again?
a osses ave our compe ors exper ence
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DOCUMENT THE RISKS
Risk ID and Text Description
Affected Outcome
Probability and Severity Ratings
Level of Manageability
Miti ation Actions s and Owner
Contingency Plan(s) and Owner
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QUANTIFY IMPACT
CAPEX cost
Project Schedule
Construction Safety
Facility Operability
Com an Re utation
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RISK ASSESSMENT AS PER ICH Q9
Risk
O S D
Number OxSxD
5.
X1
1.2 Receipt of damaged packs or containers 2 4 18
X3
1.3 Receipt of Hazardous material 1 1 1X1
1.4 Receipt of container without Label 1 5 15
X1
2.1 Wrong material sampled. 1 5 1X1
2.2 Sampling from damaged packs or containers 2 4 18
X3
2.3 Contamination of materials during sampling 1 5 15
X1
2.4 Sampling from Hazardous material 1 1 11
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RISK EVALUATION
Risk Severity+Probability Vs Detection
5. Frequent 5 10 15 20 25
4. Probable 4 8 12 16 20
3. Occasional 3 6 9 12 15
. emo e
1. Improbable 1 2 3 4 5
RATING 1 None 2 Negligible 3 Marginal 4 Critical 5 Catastrophic
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RISK MATRIX
h u m
H i g
L o
M e d i
Risk Class ONE
High y
Risk Class TWO
Medium b a b i l i t
Risk Class THREELow
P r
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DESIGN CONCEPTS
How to Avoid mix ups
Take measures to avoid contamination
Provide suitable materials flow around the facility
Provide adequate space for operations
Ade uate labellin at oint of o eration
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PREFERRED LAYOUT
Segregate raw materials and final products
Segregate different production suites involving different classes of products
Closed operations where possible
Provide distinct staging areas if required between process steps
Provide cleanable production suites and equipment
Provide suitable environments for controlled areas where products and theiractive material are stored and processed
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U SATELLITE PROCESS ASSURANCE HUB U SPAH
Adopt an overall unidirectional materials flow through the plant starting
warehouses
Maximize adjacency of materials storage with production suites
Adopt a central spine in the building in both the support areas and processarea around which materials flowed and the process functional rooms are
Maximize technical s ace ad acenc to roduction rooms
Provide IBC handling and discharge level above the process and filling rooms
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U SATELLITE PROCESS ASSURANCE HUB U SPAH
Close adjacency of the QC/QA laboratory to all operations
Minimize under utilized technical plant space and clean corridors
Provide a visitor viewing gallery through the plant which maximizes visibilityof the process areas without entering them
Analysis of final product only with no inter stage QA hold points, thus
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SATELLITE PROCESS ASSURANCE HUB SPAH
Segregated raw material and final product warehouses
Clear and separate raw materials and final product flow paths through the plant
Good access control of process personnel to production areas
v y v y u , w yuse of `through the wall technology to minimize congestion in the rooms
Convenient location for a centralized information room to facilitate theimplementation of the FDA initiative
Through the wall technology is available for each production room, allowing lesscongested process rooms easier to clean for multi product facilities
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CLOSED TRANSFERS
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VACUUM LOADING CLOSED LOOP
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Design concepts
RMG
FBD
Tablet Presses
en er Tablet Coater
Packaging Line
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DESIGN CONCEPT II
IBC
Potent ProductTablet PressesDissolution Vessel
FBDBlender
Tablet Coater
Packaging Line
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CONCEPT III
Single Bowl
Roto Granulator
Tablet Presses
Vacuum ConveyingVacuum Conveying
Tablet Coater Blender
Packaging Line
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FACILITY DESIGN
Flexible and Agile Facilities
Modular designs
Disposable /Dedicated Equipment
Innovation
Continuous improvement
Expandable Risk based
Use of PAT
Virtual IT networks
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MANUFACTURING EXCELLENCE
Better Quality
Higher Throughput
Greater Availability
More Productive Operations and Maintenance
,
Lower Utilit Costs
Less Waste
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CREATING OPERATIONAL EXCELLENCE
Excellence in OperationsGoal 1
Reduced manufacturing
Goal 2Improved inventory
Goal 3Better use of
assets
Goal 4Top quality and efficiency in all
Goal 5Service level excellence
costs s tuat on processes
Metric 1 Metric 2 Metric 3 Metric 4 Metric 5Revenue vs.
manufacturing costs
Coverage days of inventory
Revenue vs. manufacturing
fixed assets
Right first time On time in full delivery
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VISION FOR FUTURE
Product quality and performance achieved and assured by design of
Continuous real time assurance of ualit PAT
Regulatory policies and procedures tailored to recognize the level of scientific knowledge supporting product applications, process validation andprocess capability.
Riskbased manufacturing and quality systems
Continuous processing
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BIRD EYE VIEW
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STATE OF ART FACILITIES
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