Kick Off Meeting CoP D-A-CH PAT & LCS

Transcription

1 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 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

2 Agenda Kick Off Meeting CoP D-A-CH PAT & LCS 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 Connecting Pharmaceutical Knowledge ispe.org 2

3 WHY THIS INITIATIVE?!? REGULATORY & BUSINESS DRIVER & BACKGROUND INTRODUCTION TO THE PAT & LCS COMMUNITY OF PRACTICE

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 Process Validation Teams PQLI Regulatory & Compliance Committee GAMP Connecting Pharmaceutical Knowledge ispe.org 4 4

5 A Global Organisation Regional PAT & LCS CoP Support Global PAT & LCS CoP Steering Committee DACH US Chapters Global CoP PAT&LCS Singapore Turkey UK/Irl Nordic Connecting Pharmaceutical Knowledge ispe.org 5

6 Starting Point: FDA PAT Guidance Document in 2004 Connecting Pharmaceutical Knowledge ispe.org 6

7 What did we achieve? Created the PAT Management Awareness Document & PE Article Review of the amab Case Study Creation of PAT Data Management Document (Data Management Task Team) Connecting Pharmaceutical Knowledge ispe.org 7

8 Did we advance? Connecting Pharmaceutical Knowledge ispe.org 8

9 WHY THIS INITIATIVE?!? REGULATORY & BUSINESS DRIVER & BACKGROUND ICH Q 8, 9, 10, 11, 12 CONTROL STRATEGY

10 FDA & ICH Roadmap 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) Connecting Pharmaceutical Knowledge ispe.org 10

11 New FDA Office of Pharmaceutical Quality An FDA Perspective on Post- Approval Change Management for PAT and RTRT, Christine Moore, FDA, IFPAC 2015 Connecting Pharmaceutical Knowledge ispe.org 11

12 Control Strategy Definition in ICH Q8 (R2) Automation Aspects 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. Connecting Pharmaceutical Knowledge ispe.org 12

13 Control Strategy Definition in ICH Q10 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. Connecting Pharmaceutical Knowledge ispe.org 13

14 Control Strategy 2 Different Types/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 Connecting Pharmaceutical Knowledge ispe.org 14

15 Process Control Strategy Scope & Aspects Regulatory Filing Management Knowledge Management Compliance Data Integrity CPV Regulatory Process Control Strategy Integration E-Inspections APR/PQR Performance OEE/KPI Operator & Equipment manual / automatic data capture via HMI, PLC, DCS, SCADA PAT Connecting Pharmaceutical Knowledge 15 ispe.org 15

16 PROBLEM STATEMENT PROCESS CONTROL STRATEGY IMPLEMENTATION E.G. EQUIPMENT INTEGRATION, FLEXIBLE MANUFACTURING, FEEDBACK LOOP

17 Process Control Strategy The Challenge of Implementing the CS in Manufacturing 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. Source: Regional CoP PAT&LCS (Lifecycle Control Strategy) D/A/CH Team Charter Version 1.0, Connecting Pharmaceutical Knowledge ispe.org 17

18 Process Control Strategy The Challenge of Implementing the CS in Manufacturing 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 codeveloping operations excellence across the different departments in the pharmaceutical organizations Connecting Pharmaceutical Knowledge ispe.org 18

19 Smart Factory Pharma 4.0 What I see on the ISPE Trend Radar Manufacturing Technology Standardization Operability Lifecycle Control New input devices & operating concepts (augmented reality) Smart Equipment Continuous Manufacturing Single Use Mobile Systems devices 3D Pharmaceuticals Biotech Manufacturing Collaboration with the Regulators E-Inspections Data Integrity CPV Quality Metrics (APR, PQR) Quality Regulatory Compliance Drug Shortage Initiative Small lot sizes More product Business Global Process Harmonization Best Practice content Integration Standardization CMO Integration Drug Application Systems Personalized medicine Connecting Pharmaceutical Knowledge ispe.org 19

20 ISPE D-A-CH PAT & LCS WORKING GROUP PROJECTS INTRODUCTION TO THE PROJECTS

21 Proposed Projects Focus Process Control Strategy Implementation 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 Connecting Pharmaceutical Knowledge ispe.org 21

22 1. Process Control Strategy Implementation Awareness Document Content: Status today and the gaps 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 Connecting Pharmaceutical Knowledge ispe.org 22

23 2. IT Automation System Structure & Integration Standardization 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 Connecting Pharmaceutical Knowledge ispe.org 23

24 Create a Best Practice Communication Protocol Blueprint Level 4 ERP Systems Level 3 Systems LIMS, CAPA, Doc Management, MES, Serialization etc. Physical Data Protocols & Data Content - Standardization! Level 2 Systems Equipment, Machines, SCADA, DCS, Environmental Monitoring, Serialization Equipment etc. Connecting Pharmaceutical Knowledge ispe.org 24

25 3. QbD Workflow Execution Implementation of the Process Control Strategy 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 Connecting Pharmaceutical Knowledge ispe.org 25

26 PROJECT DISCUSSION OPPORTUNITIES TO VOLUNTEER

27 Proposed CoP PAT & LCS 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 Connecting Pharmaceutical Knowledge ispe.org 27

28 Do you want to participate? Use the Feedback Form: Weiteres Vorgehen: Bei Interesse senden Sie bitte eine Mail an Christian Wölbeling: 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. Ablauf: Arbeitskapitel definieren Inhalte je Kapitel vorbereiten Inhalte reviewen & finalisieren (f2f) Ca. 2-5 Meetings notwendig Gesamtdokumentation erstellen ISPE Review Veröffentlichung Connecting Pharmaceutical Knowledge ispe.org 28

29 Thank you for your attention. Christian Wölbeling ISPE Local CoP PAT & LCS c/o Werum IT Solutions GmbH Phone: Connecting Pharmaceutical Knowledge ispe.org 29