ISPE Annual Meeting 29 October – 1 November 2017 San · PDF fileISPE Annual Meeting 29 October – 1 November 2017 San Diego, CA 2 Key considerations when approaching QMS integration:

ISPE Annual Meeting29 October – 1 November 2017

San Diego, CA

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How to Harmonize and Simplify Quality Systems

Fredrik Asell, VP Quality Americas

Agenda

• Approaches to QMS integration

• A Case Study

• Business Process Management

• Q&A


San Diego, CA

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Key considerations when approaching QMS integration:How globally standardized is my company? (not only QMS, but as an overall company) How mature is the new partner in ”business as usual” GMP supply?

3

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Start-up R&D going commercial Mature global pharma

Standardization & Centralization

Partner GMPmaturity

Phased integration

Quickly: Issues/complaints, communications etc

Can wait: Common doc mgmt system etc

Light touch

Quickly: Issues/complaints, communications etc

COMMON

Establish baselineAuditsManagement reviewEtc

Establish key staffhighly desirable

”Be careful” / ”Build”

Will require more ”hands on” thannormal parent company approach

Transfer as much as possible from most similar site in networkConsider consultants support

Heavy integration

”Copy/paste procedures” etc

Parachute in people

Recognize people and culture too!

As the Parent Company

Respect previous identity.

Look for win-win wheneveryou can

Leverage possible new best practice.

Common

Agree expectations early

Not everything is equally urgent: agree on priorities

As the Acquired Company

Come to terms: this will happen.

Look for the positives

Get engaged in networks quickly.


San Diego, CA

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An Example QMS Project From the Plant Network

Background• Medimmune acquired by AZ in 2007.

• Operated for a number of years on existing SOP’s and systems (Light Touch approach).

• Focus on biologics pipeline.

• As products launched the focus shifted to commercial execution.

• Mid 2016 new management in many key positions at the site from top 5 firms start to ask questions.

• AstraZeneca overall had also shifted towards standardized global ways of working

This change control process is more complex and effort than I’m use?

It seems like the events and minor deviations are taking a lot of effort for

low risk issues?

It seems like controls could be enhanced to

ensure new GMP materials are controlled and risks reduced what

do you think?

It takes a week or more to get access to

document like an SOP to begin editing, I have a short term deadline!

Most of our processes are common across the AZ network; why don’t we leverage this more?


San Diego, CA

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Governance Structure and Teams

Steering CommitteeProgram Management

Deviation & CAPA

Co‐Leads: Ops & Quality

Site Process Owner:

Document Processes


Site Process Owner:

Change Control


Site Process Owner:

Materials Control

Co‐ Leads: Ops & Quality

Site Process Owner:

• Establish governance and bi-weekly steering committee meetings

• Each QMS Team had a co-lead from Ops and Quality and the Site process owner and a few SME’s

• Standardize approach to site QMS redesign starting with AZ Policy and SOP

• Standard project dashboard and schedule expectations

Phased Integration of high priority QMS and begin Process Mgt (BPM)

QMS Redesign Schedule

Task / Week November December January February March April May June

Current State Assessment

Future State Design

Implementation / Communication Plan

Document Revisions and Approvals

Communication to key stakeholders

Training Materials Development

Training

High level of Implementation Support

Key Stakeholder Engagement / Feedback

Rapid Implementation of QMS redesign for 5 key systems. Go fast with a standard project approach and engaged governance.


San Diego, CA

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Project Plan

Step 1 – Current State

- Establish steering team

- Teams populate current state template

- Complete charter and approval

Month 1

Step 2 – Future State

- Start with AZ corp QMS

-Benchmark industry good practices to help define site SOP

-Define future state targets and process and SOP

Month 2

Step 3 – Implementation Plan

-Create implementation plans

-Assess and mitigate implementation risks

- Develop communication and Change mgt. plans

Month 3

Step 4 – Implementation

- Document approvals & Training

-Retire old Medimmune Corp SOP’s

- Increased communication & support during implementation

Month 4-6

Simplify Quality Systems Program Status – Example

Current Status Previous Status Key Milestone /Deliverable Owner Due Date Latest Estimate Actual Comments

G Y Project VSCR and Tasks Week of 10Apr Complete Rec#163200, approved on 13Apr17.

G Y Site Communication Week of 10Apr Complete Distributed on 13Apr17.

G Y DMS Implementation 17Apr17 Complete VSCR Tasks for DMS Implementation are closed.

G Y Dev Mgt Implementation 17Apr17 Complete VSCR Tasks for Deviation Implementation are closed.

G G CAPA Implementation 28Apr17 Complete VSCR Task pending closure.

G G Change Control Implementation 31May17 On Track Documents (6) revision/creation in progress. Training materials development in progress.

G G MM Implementation 30Jun17 On Track Phased Implementation (iBuy and New Materials)Documents (10) revision/creation in progress. Training materials development in progress.

G Poster Session 03May17 On Track Posters ready for printing


San Diego, CA

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The Challenges• Multiple PAI’s • Multiple audits• Project Time for the team leads and owners while doing current role• Alignment of Stakeholders on future state system• Changes to corporate systems like TrackWise at the same time• Meeting aggressive schedules for design and implementation

The Results • Established process ownership of each of the major QMS elements• Eliminated reference to old Medimmune procedures• Simplified procedures to AZ standard and industry best practice

– Improve effectiveness • Improved cycle time •Refocused to risk based approach

–Reduced level of effort on low risk areas–Increased focus on medium and high risks

• Improved clarity of roles and responsibility• Improved Consistency in QMS execution

–Reduce compliance risk


San Diego, CA

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Operations PQS ‐ BPM Based with Foundation in ICHQ10

13 core elements

+ 15 sub-elements

= 28 BPOs

PC

Executive Process Owner

• Sets the strategic direction & targets for theprocess

• Holds a holistic overview to ensure alignment across related processes

• Sponsors the process and supports the BPO

EPO

Process Champion

• Champions the process in own site / region / function

• Represents their area in process design & improvement

• Trains & coaches local end user community

• Ensures adherence to process with users & local management

• Shares good practice & improvement ideas from own area

PE

Business Process Owner

• Operational leadership of the process

• Defines & owns the standard process

• Provides training & communications

• Monitors process adherence

• Monitors process performance & drives improvement

• Leads a cross-functional process network

• Manages links with related processes

• Manages any supporting systems / IT

BPO

LM

Line Manager

• Ensures adherence to the agreed process

• Ensures appropriate capability and succession planning for process users

• Supports BPO in process improvement

Process Expert

• Provides deep subject matter expertise in the process

• Supports BPO & process champions in training & coaching users

Operations BPM Roles


San Diego, CA

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Quality Global BPM Model

Site

Users

Global

BPO

RPC

Function Users

Regional Process

Champion

Functional Process

Champion

Regional Process

Champion

Regional Process

Champion

Site Process

Champion

Site Process

Champion

Site Process

Champion

GlobalProcessNetwork

RegionalProcessNetwork

User User

UserUser

User

User

User

User

Networks & Forums3 41 2

BPM Maturity

Level


San Diego, CA

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Questions and Answer