pharma 4.0 and lims -...

PHARMA 4.0 AND LIMS

Jenny

©2018 InnoArk Pte. Ltd. All Rights Reserved.2

What is Pharma 4.0?

©2018 InnoArk Pte. Ltd. All Rights Reserved.

What is Pharma 4.0

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Industry 4.0 as the convergence of people, physical systems, and datawithin an industrial process to increase quality, productivity and profit by using the power of advanced data analytics.

Pharma 4.0 can be defined in the same way


What’s driving pharma towards Pharma 4.0?

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Meeting GMP Regulations

• Continuous Product Monitoring

• In past, annual product quality review is not necessarily ideal

• But now, there is a growing expectation for manufacturers to perform review more than annually

• Careful Control of Operation to produce critical medicines

Competition

• The demand of high drug quality

• Prolong the shorter drug life cycle

• Reduce high cost of batch manufacturing

• The needs of providing more personalized therapies


How Pharma 4.0 can benefit to businesses

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Challenges to Pharma 4.0


1. Cost of upgrading legacy systems but this

can be quickly offset by tangible results:

higher productivity and reduction in

downtime and waste.

2. Finding adequately skilled manpower with

advanced skill sets such as advanced

analytical skills.

3. A lot of islands information will be another

concern – To completely reap the benefits of

Pharma 4.0, it would mean to connect

hundreds and thousands of devices such as

sensors, machines and network with each

connection to be a potential point of

interest. To effectively mitigate this risk,

companies will need to build data lake and

have to become more open to investing in

skilled cyber-security personnel.

Challenges in Pharma 4.0


What is the relationship between Pharma and Lims?


Pharma 4.0 Operating Model

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ISPE’s Pharma 4.0 Special Interest Group (SIG) has developed an operating model for moving from Industry 4.0 to Pharma 4.0 which is shown in the image below


Pharma 4.0 Operating Model

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InLIMS is in one of the Pharma 4.0’s operating model element (Information Systems).


Introduction


What is InLims?

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Designed specially for

Pharmaceutical

Adhere to CFR 21 Part 11

guidelines

Adhere to Good Manufacturing

Practices (GMP)


InLims Business Values

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Gain data visibility

Remove error in lab operation

Enhance quality

process

Enhance regulatory

compliance

Increase lab

productivity


Modules


InLims Modules

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inLIMSMaster

Management

Samples Registration

Samples Conditioning

Result Management

Reports

Dashboard / Analytics


InLims Modules

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inLIMSMaster

Management



Result Management

Reports


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Master Management

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Master Management

Testing Type

GC, HPLC, Micro etc

Parameters

Chemical

Kadar

KeseragamanKandungan

Disolusi

Physical

Ketebalan

Kekerasan

Waktu Rapuh

Visual

Tablet

Capsule

Syrup

Suspension

Products

Spec / Control Limit

Parameters To Be Tested

Manual / Direct

Integration


InLims Modules

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inLIMSMaster

Management



Result Management

Reports




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Samples Registration is one of the main modules in InLims to register the lab samples for testing.

Key Features:

Batch Number

Translation

Conditioning Requirements

Lab Test Requirements

Barcode Generation



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Barcode Label

The barcode label is highly customized based on customer requirement.It can be designed in QR code or UCP barcode.

The barcode label will be used to stick into the physical lab samples.


InLims Modules

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inLIMSMaster

Management



Result Management

Reports


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Conditioning

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Conditioning Duration Record

Conditioning Reminder

Stop Conditioning

Samples Conditioning is one of the required modules in InLims if you want to do stability test on the lab samples.

Key features:


Conditioning

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Conditioning Reminder


InLims Modules

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inLIMSMaster

Management



Result Management

Reports



Result Management

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Input Result

• Entry lab test result for:

• Chemical

• Physical

• Visual

• Formula for following chemical parameters have been digitize:

• Content Determination

• Content Uniformity

• Dissolution

QA/QC

• Highlight result based on the spec/control limit

Approval Workflow

• 2 approval level:

• Lab Supervisor

• Lab Manager


InLims Modules

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inLIMSMaster

Management



Result Management

Reports


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Report

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Report

Published Report

COA Report

Trend ReportAnnual Product

Review Report

E-signature is available in the system and will be printed in the reports.


Report

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Trend Report


InLims Modules

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inLIMSMaster

Management



Result Management

Reports


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Dashboard

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Our workshops


Assessment Model for Pharma 4.0

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Vision

People

Organisation

Programs and Methods

Performance Driving System

Business Operational Excellence

Factory Strategic Plan

MISSION

VOLUMES

PRODUCTS

ECOSYSTEM


Workshops for Pharma 4.0

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Industry 4.0 Mini Series

(2 days)

• To understand key concepts of Lean

• How Lean related to industry 4.0

Implementing Lean Six Sigma

(3 days)

• Understand Lean Six - Sigma

• Apply Six-Sigma methodology

• Identify opportunities for process improvement

• Know the synergy between Lean and Six Sigma

• Benefits of Lean Six-Sigma

Industry 4.0 Readiness Assessment

(1 day)

• To understand your readiness before moving to Industry 4.0

pharma 4.0 and lims -...

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