New Concepts in Pharma Facilities

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

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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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Documents

New Concepts in Pharma Facilities