Pharmaceutical  Facilities
 

Sanjit  Singh Lamba
Managing Director

Eisai Knowledge Centre, Vizag, India

 

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 %
 

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

•
 

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.

 

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

 

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

 

QUANTIFY IMPACT

•   CAPEX cost

•   Project Schedule

•   Construction Safety

•   Facility Operability

•   Com an Re utation
 

RISK ASSESSMENT  AS PER ICH  Q9

Risk
 
O S D  Number 
OxSxD

5
.
X1
8
1.2 Receipt of damaged packs or containers 2 4 1
X3

1.3 Receipt of Hazardous material 1 1 1

X1
5
1.4 Receipt of container without Label 1 5 1
X1

2.1 Wrong material sampled. 1 5 1

X1
8
2.2 Sampling from damaged packs or containers 2 4 1
X3
5
2.3 Contamination of materials during sampling 1 5 1
X1
1
2.4 Sampling from Hazardous material 1 1 1
 

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

 

RISK MATRIX

    m
    u
     i      h
    o      d     g
     i Risk Class  ONE
     L     e      H
     M

High Risk Class  TWO

    y
    t
     i
     l
     i
     b Medium
    a
     b Risk Class THREE
    r
     P
Low
 

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

 

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 their
active material are stored and processed
 

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 process
area 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
 

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 visibility
of the process areas without entering them

•   Analysis of final product only with no inter‐stage QA hold points, thus

 

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 y
use of `through the wall’ technology to minimize congestion in the rooms

•   Convenient location for a centralized information room to facilitate the

implementation of the FDA initiative

•   Through the wall technology is available for each production room, allowing less
congested process rooms easier to clean for multi product facilities
 

CLOSED TRANSFERS

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VACUUM LOADING –CLOSED LOOP

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Design concepts

RMG

Tablet Presses
FBD

en er  
Tablet Coater 

Packaging Li ne
 

DESIGN CONCEPT ‐ II

IBC

Potent Product
Dissolu tio n Vessel Tablet Presses

FBD

Blender 
Tablet Coater 

Packaging Li ne
 

CONCEPT ‐ III

Single Bowl
Roto Granulator 

Tablet Presses

Vacuum Conveying

Blender  Tablet Coater 

Packaging Li ne
 

FACILITY DESIGN

•   Flexible and Agile Facilities

Modular designs

  Disposable /Dedicated Equipment

   Innovation

  Continuous improvement

   Expandable

  Risk based

  Use of PAT

  Virtual IT networks
 

MANUFACTURING EXCELLENCE

•   Better Quality

•   Higher Throughput

•   Greater Availability

•   More Productive Operations and Maintenance

•   Lower Utilit Costs

•   Less Waste
 

CREATING OPERATIONAL EXCELLENCE

Excellence in Operations
Goal 1 Goal 2 Goal 3 Goal 4 Goal 5
Reduced  Improved  Better use of   Top quality and  Service level 
manufacturing  inventory  assets efficiency in all  excellence
costs s tuat on processes

Metric 1 Metric 2 Metric 3 Metric 4 Metric 5

Revenue vs.  Coverage days of   Revenue vs.  Right first time On time in full 
manufacturing  inventory manufacturing  delivery
costs fixed assets

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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 and
process capability.

•   Risk‐based manufacturing and quality systems

•   Continuous processing

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BIRD EYE VIEW
 

STATE OF ART FACILITIES

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