Welcome

BizBites & tQmlab®BizBites is a Business Intelligence and Technology Enabled Solutions provider based out of UK since 2004, we also have our presence in India since 2011.

tQmlab® is one of the premier management system for GxP operations and for enabling regulatory submissions. It delivers transformational productivity for QA/QC labs supporting customised workflows for quality control of drugs, stability testing, product release testing and post-release quality testing.

tQmlab® with its integrated E-Lab Notebook, enables PAT based controls in pharmaceutical manufacturing and analytical processes through the measurement of Critical Process Parameters (CPP) which affect Critical Quality Attributes (CQA).

Agenda

Principles and Benefits of PAT

Systems Approach to PAT (QbD)

tQmlab® – Features and Benefits

Presented by Pradeep Mocherla

The answer is multivariate and transient.It depends on who is asking the question,and who is giving the answer.

Technologists

Managers

Quality andRegulatory Groups

Support Groups

IT,Engineering, Maintenance

What is PAT?

Automation

Reactor

Control Room

Probe

AnalyticalInstrument

Automation

Reactor

Control Room

Probe

AnalyticalInstrument

Reactor In-Plant Laboratory

SampleValve

Pfizer

Reactor In-Plant Laboratory

SampleValve

Pfizer

Manual

Online PAT system

Achieving a Seamless Process

Where does PAT begin (and end)?Co-development or

Continuous Improvement Activities

ManufacturingOperations

PAT Project Progression

Invo

lvem

ent

Beginning Used to determine

Critical Process Parameters

Finished Goods Used to control the process Requires formal validation

Low cost / benefit ratio

R&D orProcess Support

Opportunities to accomplish Quality

1. Correcting at the Point of Use- Repairs/ Replacements

2. Quality Control- Testing/ Inspection3. Quality Assurance- Reviews, Proto typing,

simulation, modeling, etc4. Design

Cust

omer

Sati

sfac

tion

Bran

d Im

age

Mar

ket V

alue

Cost

of d

efec

t fix

Low

High

Relia

bilit

y

Gros

s Mar

gin

1:10:100:1000 rule

Cos

t of D

efec

t fix Quality by Plan

&

not a chance !!!!

Desi

red

obje

ctive

Interpretations of Quality

QUALITYStandards compliance

TimeCost

Regulations

Perception

Satisfaction

Meeting Specifications

Aesthetics

Fitness for use

Performance

Experience

Safety

Features

Easy Maintenance

Look & Feel

Target Quality Profiling-A Perspective

Customer

Market Regulations

Research

Engineering

Business insights

Manufacturability

Installation & Service

PurchasingSuppliers

Competitor(s)

Corporate Social Responsibility

HRM)

Process Approach to Product Quality

Process Approach

There is no GOOD or BAD process

ISO 9001 Process Model

Why GMP?

Provides a high level assurance that the manufactured output is in a way that ensures their safety, efficacy and quality

Medicines are manufactured to comply with their marketing authorization

Quality is built in– Testing is part of GMP, but alone does not provide a good level

of quality assurance

Good Manufacturing Practices

1. Quality assurance2. Good manufacturing practices

for pharmaceutical products 3. Sanitation and hygiene4. Qualification and validation5. Complaints6. Product recalls7. Contract production and

analysis– General– The contract giver– The contract accepter– The contract

8. Self Inspection and quality audits

9. Personnel10. Training11. Personal hygiene12. Premises13. Equipment14. Materials15. Documentation16. GMP in Production17. GMP in Quality Control

Good Manufacturing Practices Documentation

LabelsTesting proceduresSpecifications for starting and packaging materials, for

intermediate and bulk products and for finished productsMaster formulae and Batch Processing RecordsPackaging instructions and Batch Packaging Records Standard Operating procedures (SOP's) and recordsLogbooks

Good Manufacturing Practices Good practices in production

– General– Prevention of cross-contamination and bacterial

contamination during production– Processing operations– Packaging operations

Good practices in quality control Control of starting materials and intermediate, bulk

and finished products Test requirements Batch record review Stability studies

GMP is actually Good Common Sense

Quality Management

Quality Assurance

GMP

Production and Quality Control

Quality Management

The basic elements are:– An appropriate infrastructure or “quality system” encompassing the

organization structure, procedures, processes and resources

– The systematic actions necessary to ensure adequate confidence that a product (or service) will satisfy given requirements for “Quality”

– The concepts of GMP, quality control and quality risk management are interrelated aspects of quality management, and should be the responsibility of all personnel.

The totality of these actions is referred to as “Quality Assurance”

The five P's

Premises

Primary materials

People

Procedures

Processes defined and recorded

Basic requirements for GMP

Clearly defined and systematically reviewed processes Qualification and validation is performedAppropriate resources are provided:

Qualified and trained personnel Premises, space, equipment and services Materials, containers, labels Procedures, storage, transportLaboratories and in-process control

Basic requirements for GMP

Clear, written instructions and proceduresTrained operatorsRecords of actions, deviations and investigationsRecords for manufacture and distributionProper storage and distributionSystems for complaints and recalls

GAMP

The Good Automated Manufacturing Practice (GAMP) Forum was founded in 1991 by pharmaceutical industry professionals in the United Kingdom to address the industry’s need to improve comprehension and evolving expectations of regulatory agencies in Europe.

Computer system validation following GAMP guidelines requires users and suppliers to work in concert so that responsibilities regarding the validation process are understood.

GAMP

As a voluntary program, GAMP offers both challenges and benefits. The top three challenges in implementing GAMP are:– establishing procedural control, – handling management and change control, – and finding an acceptable standard among the existing

variations.

How a Quality System assists Validation FDA believes that companies with effective Quality Systems provide

the best environment for deploying software

The repeatability and control over events that are essential for the development of auditable systems are best provided by a formal quality system.

Systems regulate:• What actions are taken on a project• How they are executed, and by whom• What steps are to be taken to confirm that they

have been implemented correctly

Attributes contributing to Product Quality

Critical to Quality (CTQ)

Implicit Requirements

Explicit Requirements

Getting all the Product Requirements is the first step to plan for Quality

Continuous Quality Verification

ProcessDoing what Business Does

Inputs Metrics

Data

Evaluation

Requirements

DRoot CauseAnalysis

Action

MaterialsMethods(Wo)MenMachines

CostScheduleQuality (Compliance)

Process Analytics

Well Controlled Process Model

Product Development Lifecycle

System Requirements Design Development Integration V&V

Why do PAT?

Process Control Process Knowledge

Improved quality. Improved safety.

Improved Profits.Fundamental Goals

Well Controlled Process

RFT

PAT Implementation Team

PATProject

PATChampion

RFTChampion

ManufacturingOperations

R&D(co-dev)

QualityOperations

Engineering

Regulatory

Environmental,Health and Safety

ValidationServices

Automation

InformationTechnology

Management

Maintenance

Tech Services(KPT or PPT)

PASG

Implementation of a PAT requires input from a multi-disciplinary team.

GAMP Model for Validation

User Requirements

Functional Specifications

Design Specifications

Installation

Installation Qualification

Operational Qualification

Performance Qualification

Critical Decision Factors

Clarity on Product RoadmapIntended UseHardware v/s software budgeting in System DesignTarget Markets(s)Phase In-Phase Out PlanProduct EOL, EOP, EOSMake-Buy, In-house - Outsource decisionStandardization activitiesBudgeting between Hardware & SoftwareChange Management Process automation v/s resource intensive processes

More Questions

Is the information used for material release?Do components come into direct contact with product?Is there a GMP Impact?Is there a Regulatory Impact?Does the system affect product quality?What if the system fails?How should the data be archived?

What are you going to do with the data?

Really asking:Is the PAT for Process Knowledge or Process Control ?

Answer: Quality Impact Assessment

URS

User RequirementsSpecifications

QIA

QualityImpactAssessment

Ready forRoutine

Operation?

Implementation Process

DefineRequirements

PAT TeamPASG

VendorProject TeamPASGValidation Services

ProductionQualityPAT Champion

Cost review, justification, vendor selection,and approval

FAT, SAT, installation,qualification

Applicationverification

DefinitiveCPA

Capital ProjectApproval

FDS

FunctionalDesignSpecifications

IQ/OQ

Installation and Operation Qualification

PQ

Performance Qualification

Lifecycle Docs• Analytical Methods• Operation SOPs• Maintenance SOPs• Training Docs• Change Control• Periodic Review•Business Continuity Plan

Cross SiteLearning

Project TeamPASGVendor

RoutineOperation

Use of PAT to Achieve RFT Benefits

Reduce/eliminate unauthorized deviationsImprove customer service (product availability)Reduce cycle times (operational efficiency)Reduce inventory levels (save money)Reduce costs (rejects, shutdowns, reworks, etc)Improve capacity utilizationImprove compliance (reduce deviation reports)Improve quality assurance

Features in tQmlab ®Sample managementInstrument and application integrationElectronic data exchangeAudit managementBarcode & RFID integrationChain of custodyComplianceCustomer relationship managementDocument managementInstrument calibration and

maintenance

Inventory and equipment managementManual and electronic data entryMethod managementPersonnel and Certification managementQuality assurance and controlDashboard Metrics and Management

ReportsProject trackingTraceability and complete audit historyFlexible workflows for each unit.

Your responsibility

You have to maintain various standards

You end up having to do this…

You have to manage these…

Auditor

Which keeps them happy!!

Ways in Which Manual Processes Effect Profits

Wasting time in doing repeated works

Passion for science is dominated by Management of work.

Reporting is the most time taking task

• Regular audits keeps us on toes • Nearly half of our time is spent with auditors, instead of spending for customers and

business• More focus is on administration, rather than on business• Managing Multiple Labs at different locations is the toughest job

Lab Technicians

Lab Managers

Management

• Business (Repeated Business and New Business)• Customer Satisfaction • FDA Approvals• Competition• Audits• Administration & Labor Costs

Use PAT to increase your PAT

Our software helps you to increase your PAT (Profit after taxes) by implementing Process analytical technology (PAT) to each of the process control points using the respective modules.

The modules on activation are internally linked and work hand in hand to improve the efficiency at work.– For ex: The software ensures that only calibrated instruments are available for selection

at the time of result entry in the My Works process of the Lab Module. The calibration information is maintained in the Calibration module of the software.

– By enabling over the shoulder signatures for result entry where the result is based on observation of physical characteristics of the sample reduces the risk of error in result reporting and in turn reduces the time spent in doing an investigation on a later date.

Why Lab Automation?With Automation of Lab gains can be made in the following areas

Efficiency – No wastage of time, Quick reporting, No errors

Productivity – No repeated work, Data at finger tips, Quick

decisions

Accuracy – Predefined SOPs, System driven procedures, Alerts

& well maintained instruments

Security – Unique user id & Passwords, Role based privileges

Regulatory Compliance – With Authoring Wizards all the

regulatory compliances can be met

Quality Control – Data capturing, Streamlined Lab activities

Future intangible benefits

Employee morale

Customer satisfaction

The organization's

competitive orientation

Future tangible benefits

Business - New & Repeated

ROI

Benefits of Lab Automation

Error free Validations that ensure error free analysis and reporting and also the ability to create certified

workflows in the system.

Error free Workflows – With predefined workflows there is a very little room for any kind of errors as system

would be driving tests as per defined standards

Retrieval of data – All observations are captured electronically for future review and audit.

Approval workflow for reports – All automated hence providing savings in administrative time, paperwork and

significantly process time.

Sample Validity – System can ensure that no out of scope/out of spec samples are put through lab and hence

inaccurate results are not reported.

Knowledge Retention - As the system is designed to guide users through the steps of testing and hence even a

fresher can process tests (guided by the system) with reviews being conducted by experts. Hence fast growth or

loss of key staff does not impend the work of the lab which can be guided through automated procedures.

Records Protection - Loss of Documentation and Reports will be avoided.

• Ease of Access: Lab Staff, Management, Consultants and even clients (Limited to see their reports history)

• Barcode/RFID Integration: Integration with Barcode Generation software will be done for sample &

instrument management. RFID Integration can be done for high value consumables for tracking and

monitoring of usage & any unauthorised access with instant alerts to security personnel* (Can be

provided if Inventory/Stock Management module is integrated with the application)

• Instrument Calibration and Certification Management –

• Entire instrument management can be done

• Instrument maintenance and calibration schedules can be tracked and would alarm with alerts

• Batch Test Certificates:

• Templates to ensure faster and easier reporting.

• Automatic generation of test certificates with Digital Signatures based on each unique approver.

• Consultant’s Review Workflow: Ability to manage and map data to consultants/expert for each customer

so that consultants get early warning of any test results and these can be reviewed, commented by

consultants on the system before the results are approved and results are given to customers.

• Management of Training & Trainee Staff

Benefits of Lab Automation

• Highly matured workflow system• Easily customizable to user requirements• A very fast, efficient and easy to use System• Completely web based 24/7 available system• Developed using Microsoft Enterprise Technologies

• Reduce

• Product recalls.

• Cost of labour & Increased sample loads

• Transportation costs

• Cost of printers, copiers, toner, file storage boxes and shelf space, the labour work to collate, file and retrieve paper, the risk of lost files

• Eliminate most of admin activities and let Scientists to do more science.

• Save nearly

60% of Time & Money spent for audits

80% of transportation cost, moving across multiple labs located at different places

100% of time saved in terms of calculations and typing reports for scientists

ROI

Case study of tQmlab® at Intertek Plc - UK

Modules ImplementedLab - Sample managementInstruments & Calibration ManagementAsset ManagementControl Sample managementStability ManagementTraining ManagementWorkflow Management

Benefits and ROI 80% paperless office 50% time saving for scientists and

lab Admins and management 50% time saving on Audits Error free validations Error free workflows Instant retrieval of data Knowledge Retention High level of Regulatory

Compliance (100% ROI within two years)

Case Study of tQmlab ® at Megsan Labs Pvt. Ltd. - Hyderabad

Modules ImplementedLab - Sample managementDocument ManagementInvoice ManagementPeople ManagementWorkflow Management

Benefits and ROI 70% paperless office 50% time saving for scientists and lab

Admin and management 50%Time saving on Audits Improved ownership towards tasks All lab operations in single platform Error free validations Error free workflows Instant retrieval of data Knowledge Retention High level of Regulatory Compliance (It

gives 100% ROI with in 18 months)

Q&A