Kick Off Meeting CoP D-A-CH “PAT & LCS” - ISPE · PDF fileAs e.g. ISPE...

AUTOMATION IN DER PHARMAINDUSTRIE –

TREIBER, LÖSUNGEN UND TRENDS

WAS BEDEUTET DIE ICH/Q8 - 12 GMP MANUFACTURING PROCESS

„CONTROL STRATEGY” FÜR DIE ZUKÜNFTIGE AUTOMATISIERUNG?

ISPE COMMUNITY OF PRACTICE/COP

„PAT & LIFECYCLE CONTROL STRATEGY“

Kick Off Meeting CoP D-A-CH “PAT & LCS”Reinach / Basel

31.3.-1.4.2016

Christian Woelbeling

Member of the ISPE:

Global Steering Team Member CoP „PAT & LCS“

KNC Council Secretary

PDPS Council Member

DACH Affiliate Member

c/o Werum IT Solutions GmbH

Connecting Pharmaceutical Knowledge ispe.org

1. Why this initiative?!? – Regulatory & Business Driver & Background

Introduction to the PAT & LCS Community of Practice - History

ICH Q 8, 9, 10, 11, 12 – “Control Strategy“

2. Problem Statement

Process Control Strategy Implementation e.g. Equipment Integration, Flexible Manufacturing, Feedback Loop

3. ISPE D-A-CH PAT & LCS Working Group Projects

Introduction to the Projects

4. Project Discussion

Opportunities to Volunteer

AgendaKick Off Meeting CoP D-A-CH “PAT & LCS”

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WHY THIS INITIATIVE?!? –REGULATORY & BUSINESS DRIVER & BACKGROUND

INTRODUCTION TO THE PAT & LCS COMMUNITY OF PRACTICE

Connecting Pharmaceutical Knowledge ispe.org 4

• Active Pharmaceutical Ingredients

• Biotechnology

• Disposables

• Oral Solid Dosage

• Process Analytical Technology & Lifecycle Control Strategy

• Product & Process Development

• Sterile Products Processing

• Commissioning & Qualification

• Containment

• Critical Utilities

• Sustainable Facilities/HVAC

• Packaging

• Project Management

• Investigational Products

• Operations Management

GAMP®

• Process Validation Teams

• PQLI

• Regulatory & Compliance Committee

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A Global OrganisationRegional PAT & LCS CoP Support

Global PAT & LCS CoP Steering Committee

DACH

UK/Irl Nordic

Turkey

SingaporeUSChapters

Global CoPPAT&LCS


Starting Point: FDA PAT Guidance Document in 2004


Created the “PAT Management Awareness Document” & PE Article

Review of the aMab Case Study

Creation of “PAT Data Management Document” (Data Management Task Team)

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What did we achieve?


Did we advance?

WHY THIS INITIATIVE?!? –REGULATORY & BUSINESS DRIVER & BACKGROUND

ICH Q 8, 9, 10, 11, 12 – “CONTROL STRATEGY“


QbD / Risk & Science based Approach of the FDA & EMA

ICH Q 8 (R2) Pharmaceutical Development

ICH Q9 Quality Risk Management

ICH Q10 Pharmaceutical Quality System

ICH Q 11 Development and Manufacture of Drug Substances (planned end 2016)

ICH Q 12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle

Management (planned for June 2018)

FDA & ICHRoadmap


New FDA Office of Pharmaceutical Quality

An FDA Perspective on Post- Approval Change Management for PAT and RTRT, Christine Moore, FDA, IFPAC 2015


A control strategy can include, but is not limited to, the following:

Control of input material attributes (e.g., drug substance, excipients, primary packaging materials) based on an understanding of their impact on process ability or product quality;

Product specification(s);

Controls for unit operations that have an impact on downstream processing or product quality (e.g., the impact of drying on degradation, particle size distribution of the granulate on dissolution);

In-process or real-time release testing in lieu of end-product testing (e.g. measurement and control of CQAs during processing);

A monitoring program (e.g., full product testing at regular intervals) for verifying multivariate prediction models.

A control strategy can include different elements. For example, one element of the control strategy could rely on end-product testing, whereas another could depend on real-time release testing. The rationale for using these alternative approaches should be described in the submission.

Adoption of the principles in this guideline can support the justification of alternative approaches to the setting of specification attributes and acceptance criteria as described in Q6A and Q6B.

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Control Strategy Definition in ICH Q8 (R2)Automation Aspects


A planned set of controls, derived from current product and process understanding, that assures process performance and product quality. The controls can include parameters and attributes related to drug substance and drug product materials and components, facility and equipment operating conditions, in-process controls, finished product specifications, and the associated methods and frequency of monitoring and control. (ICH Q10)

ICH guideline Q8, Q9 and Q10 - questions and answers volume 4

„A control strategy is required for all products. If a Design Space is developed and

approved, the Control Strategy [see ICH Q8(R2), Part II, Section 4] provides the mechanism to

ensure that the manufacturing process is maintained within the boundaries described

by the Design Space.”

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Control Strategy Definition in ICH Q10Automation Aspects


Submission Control Strategy Basis in ICH Q8 (R2) – Pharmaceutical Development Drug substance / product focus CQA & CPP & CMA per submission

Commercial Manufacturing GMP Process Control Strategy Plus GMP controls Environmental controls Equipment & Facilities controls Automation Control Strategy Not direct product related CQA & CPP E.g. Purity, iron test CQAs

Environmental, Health, and Safety / EHS controls

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Control Strategy – 2 Different Types/Aspects


Regulatory Filing Management

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Process Control StrategyScope & Aspects

Process

Control

Strategy

Operator & Equipment

manual / automatic data capture via HMI, PLC, DCS, SCADA

Integration

PAT

Compliance

Regulatory

Data Integrity

CPV

Knowledge Management

E-Inspections

OEE/KPI

Performance

APR/PQR

PROBLEM STATEMENT

PROCESS CONTROL STRATEGY IMPLEMENTATION

E.G. EQUIPMENT INTEGRATION, FLEXIBLE MANUFACTURING, FEEDBACK LOOP


Problem Statement:

1. The current Manufacturing Processes are mostly still not QbD based and do not follow a flexible manufacturing process. The new Risk & QbD approach based on ICH Q 8 to 12 Guidelines is not yet fully applied nor daily manufacturing practice.

2. Our Manufacturing suites / machines are only partially networked and don’t support horizontal & vertical integration…

3. Good and established PAT Sensors are available and proven. The feasibility of the technology is established and it needs the commercial manufacturing routine. The Operational GMP Process Control Strategies for Manufacturing Execution are not yet well implemented into the Manufacturing Execution Landscape (e.g. Equipment, IT Systems, Manufacturing Best Practices) Integration and Qualification of PAT methods / sensors in Manufacturing machines / networks and the related Data Management & Representation, Change Management, Knowledge Management & Data Integrity aspects are not implemented yet.

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Process Control StrategyThe Challenge of Implementing the CS in Manufacturing

Source: Regional CoP “PAT&LCS (Lifecycle Control Strategy)” D/A/CH Team Charter Version 1.0, 3.2.2016


Vision & Mission:

“As the ISPE is the home of all kind of pharmaceutical professionals we as the community are able to break down the walls between the silos and pave the road for

“a maximally efficient, agile flexible pharmaceutical sector that reliably produces high quality drugs without extensive regulatory oversight”

at reasonable cost.

ISPE is the right platform to interdisciplinary engineer best practices to implement the Process Control Strategy in commercial manufacturing by co-developing operations excellence across the different departments in the pharmaceutical organizations”

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Process Control StrategyThe Challenge of Implementing the CS in Manufacturing

Connecting Pharmaceutical Knowledge ispe.org19

Smart Factory – Pharma 4.0What I see on the ISPE Trend Radar

Manufacturing

Technology

BusinessLifecycle

Control

Best

Practice contentGlobal

Process

Harmonization

Mobile

devices

New input devices

& operating concepts

(augmented reality)

Smart

Equipment

Biotech

Manufacturing

Single Use

SystemsE-Inspections

Data Integrity

Quality Metrics

(APR, PQR)

Small lot sizes

More product

Personalized medicine

CMO

Integration

CPV

Operability

Standardization

Quality

Regulatory

Compliance

Drug Application Systems

Drug

Shortage

Initiative

Continuous

Manufacturing

3D

Pharma-

ceuticalsCollaboration

with the

Regulators

Integration

Standardization

ISPE D-A-CH PAT & LCSWORKING GROUP PROJECTS

INTRODUCTION TO THE PROJECTS


1. “Process Control Strategy Implementation Awareness Document”

Status today and the gaps

Roadmap for future implementation and the impact on Data Integrity

As e.g. ISPE Pharmaceutical Engineering Article

2. IT Automation System Structure & Integration Standardization

Blueprint for a “Best Practice” based system architecture implementation (S95 Level 2 to Level 3)

As e.g. ISPE Guidance Document

3. “QbD” Workflow Execution – The Process Control Strategy

Methods for the MVDA based Process Control Strategy (Basis e.g. aMab Study Page 90 - from

description to feedback control) incl. a predictive process control

As e.g. Extend the ISPE “aMab Study” by the Process Control Strategy Implementation

Proposed ProjectsFocus Process Control Strategy Implementation

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Content:


Summarize the content, impact & goals of the ICH Q8 to 12 in regard to the Process Control Strategy

Roadmap for future implementation (e.g. System Blueprints)

Impact on Data Integrity

Goals:

Explain the importance of the Control Strategy in the FDA paradigm to the industry

Explain the Importance of the collaboration of QA, Engineering, Manufacturing etc. for implementing the Control Strategy

Create awareness on management level

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1. Process Control Strategy ImplementationAwareness Document


Content:

IT System Communication Blueprint

IT System Infrastructure Blueprint

Horizontal Equipment Communication Protocol (e.g. Similar to the VDMA XML Standard)

Vertical equipment standardization technique and protocol

Goals:

Secure Data Integrity in equipment integration / communication

Involve VDMA, NAMUR, VDI, ISA, OPC Foundation, Open SCS as necessary

Global standard like in Semiconductor

Create a “Guideline” e.g. together with GAMP

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2. IT Automation System Structure &Integration Standardization


Create a Best Practice Communication Protocol Blueprint

Level 2 Systems

Equipment, Machines, SCADA, DCS, Environmental Monitoring, Serialization Equipment etc.

Level 3 Systems

LIMS, CAPA, Doc Management, MES, Serialization etc.

Level 4 ERP Systems

Physical Data Protocols & Data Content - Standardization!


Content:

Methods for the MVDA based Process Control Strategy

Basis e.g. aMab Study Page 90 - from description to feedback control incl. a predictive process control

Application for Bio-Products & Biosimilars

Goals:

Create a practical example for the implementation / automation

Extend the ISPE “aMab Study” by the Process Control Strategy Implementation

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3. ”QbD” Workflow Execution Implementation of theProcess Control Strategy

PROJECT DISCUSSION

OPPORTUNITIES TO VOLUNTEER


1. “Process Control Strategy Implementation Awareness Document”


Roadmap for future implementation and the impact on Data Integrity

As e.g. ISPE Pharmaceutical Engineering Article

2. “IT Automation System Structure & Integration Standardization”

Blueprint for a “Best Practice” based system architecture implementation (S95 Level 2 to Level 3)

As e.g. ISPE Guidance Document

3. “QbD Workflow Execution – The Process Control Strategy”

Methods for the MVDA based Process Control Strategy (Basis e.g. aMab Study Page 90 - from

description to feedback control) incl. a predictive process control

As e.g. Extend the ISPE “aMab Study” by the Process Control Strategy Implementation

Proposed CoP “PAT & LCS” Projects

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Do you want to participate? Use the Feedback Form:

Weiteres Vorgehen:

1. Bildung von bis zu 3 Teams

2. Je Team 2 Co-Team Leads

3. Webex als Kick off (April/Mai)

Definition der Roadmap/Terminplan

4. Erstes F2F Arbeitsmeeting (Mai/Juni)

Interdisziplinäre Teams:

Pharma Industrie Maschinen Hersteller Systemlieferanten Automation Anlagenbau Hochschulen Regulatoren Etc.

Bei Interesse senden Sie bitte eine Mail an Christian Wölbeling:

[email protected]

Ablauf:

Arbeitskapitel definieren Inhalte je Kapitel vorbereiten Inhalte reviewen & finalisieren (f2f)

Ca. 2-5 Meetings notwendig

Gesamtdokumentation erstellen ISPE Review Veröffentlichung


Thank you for your attention.

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Christian WölbelingISPE Local CoP „PAT & LCS“

[email protected]

c/o Werum IT Solutions GmbH

Phone: +49 4131 8900-49

[email protected]

www.werum.com

mailto:[email protected]

mailto:[email protected]

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