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How to implement the electronic manuafacturing guides in pharma industry.

How to implement the electronic manuafacturing guides in pharma industry.

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  • Esto es un ejemplo del concepto de gestión de Orden de FabricaciónLas ordenes se crean manualmente o mediante el interfase ERP para un proceso y una guía (producto) por parte del usuario Supervisor que puede gestionar la liberación y el avance durante la ejecución de las mismas.Las ordenes se descomponen en subordenes que ejecutan en una o múltiples operaciones a través de la estación de operación por parte del usuario Operador.
  • Esto es un ejemplo del concepto de gestión de Orden de FabricaciónLas ordenes se crean manualmente o mediante el interfase ERP para un proceso y una guía (producto) por parte del usuario Supervisor que puede gestionar la liberación y el avance durante la ejecución de las mismas.Las ordenes se descomponen en subordenes que ejecutan en una o múltiples operaciones a través de la estación de operación por parte del usuario Operador.
  • Esto es un ejemplo del concepto de gestión de Orden de FabricaciónLas ordenes se crean manualmente o mediante el interfase ERP para un proceso y una guía (producto) por parte del usuario Supervisor que puede gestionar la liberación y el avance durante la ejecución de las mismas.Las ordenes se descomponen en subordenes que ejecutan en una o múltiples operaciones a través de la estación de operación por parte del usuario Operador.
  • El Sistema de Guía de Fabricación tiene las siguientes posibilidades: - Planificación, priorizar, ejecutar Órdenes de Trabajo - Registro de eventos tales como consumo, producción de materiales, iniciar, detener las órdenes, etc - Modelo de producción es la base: entidades y sus relaciones - Normas de producción puede ser definidos en vigor durante la producción: el orden de las operaciones y las medidas - Los certificados se pueden aplicar en la parte de la Orden de ejecución por medio de permisos a las personas que actúen en el proceso de fabricación. Por ejemplo: el permiso para aprobar las muestras de análisis de laboratorio, el permiso de conducir una carretilla elevadora - Registro del inventario de la producción real se puede hacer. Los movimientos de materiales se registran, los eventos y las cantidades en el inventario se actualizan automáticamente. - Definición de los procesos de producción, los materiales que se utilicen y produzcan - Planificación y programación de los trabajos de producción - La gestión de trabajo: los costos? - La conectividad a la planta a través del conector de fábrica y al SAP a través del conector ERP- Software escalable, con la posibilidad de poner en práctica paso a paso la nueva funcionalidad, como la genealogía de producto.

The eManufacturing Guide v.1.0 The eManufacturing Guide v.1.0 Presentation Transcript

  • www.mesa.org2010 European Conference Unlocking Your Operations Potential November 9-10, Düsseldorf, Germany Improving operations performance through eGuides in regulated industry David Badia Principal consultant & CEO
  • 2 The following Strategic Initiatives of MESA International are associated with this presentation: Lean Manufacturing Quality & Regulatory Compliance Real-Time Enterprise
  • 3 1. Traditional manufacturing operative in question 2. Common Manufacturing Guide context 3. Implementation of a Manufacturing eGuide 4. Resources to use & how to make MeG real. 5. Almirall’s way to operations excellence 6. Continuous improvement … 7. Questions & answers. Improving operations performance through eGuides
  • 4 Processes and Operations in the pharmaceutical plants: – Specialized preparation of materials: weight and dispense • Order and recipe management systems. – Complex production processes: formulation • advanced instrumentation, control and analytical technology. • batch control systems. – High integrated conditioning and packaging lines • Supervisory, inspection and statistical quality control systems Capacity & reliability specialization & automation Traditional Manufacturing operative in question
  • 5 Processes and Operations in the pharmaceutical plants: – Production modules: granulation, mixing, drying, compression, coating, ... – Conditioning and packaging modules: filling, blistering, cartoning, packing, … – Manual activities: cleaning, sample collection, in-process quality control, format changes, equipment setup, visual inspections, … flexibility & productivity  manual supervision using paper !! Traditional Manufacturing operative in question
  • 6 Typical documentation which remains on paper: – Product related: recipes, bills of material and material safety data. – Job related: standard operation procedures, work order. – Asset related: operating instructions and “set-up” specifications. … but also: – Reports for production release and certification. – In-process control forms. – Sample collection forms for analytical quality control. – Logbooks of other daily activities. – Operation yield control records. – Annotations of exceptions, deviations and failures. Traditional Manufacturing operative in question
  • 7 1. Traditional manufacturing operative in question 2. Common manufacturing guide context 3. Implementation of a Manufacturing eGuide 4. Resources to use & how to make MeG real. 5. Almirall’s way to operations excellence 6. Continuous improvement … 7. Questions & answers. Improving operations performance through eGuides
  • 8 •Production and conditioning of pharmaceutical solid dose products: •Production: •Granulator module, •Blender module, •Tableting machine, •Coating machine. •Conditioning: •Blister line, •Cartoner machine and •Case packer. Manufacturing operations guide applied to: Common Manufacturing Guide context
  • 9 Order Scheduling Recipe Management QC Sampling operation Weight & Dispense operation Solid dosing operation Liquid formulation operation Solid formulation operation Quality Assurance Production Supervision Lot preparation at production plant level
  • 10 Weighed RM in a BIN Empty containers Weighed RM in a box Intermediate prod. containers W&D Report Box roadmap BIN roadmap Module SOP Module Logbook Manufact. Guide Machine Specs. In-Process Control Selección de evacuación posterior de Palet M.P. en SAS Comprobar Condiciones de Manipulación Inicio Pesada Etiquetado y Tarado de envase Tarado del BIN Recepción BIN Lectura de Bultos y Pesada de Materia Prima Recepción y Validación de la Paleta Aceptación de la Pesada Introducción de Materia Prima pesada en el BIN Evacuación de la paleta y comprobación peso SAS Llenado de paleta vacía con bultos pesados Limpieza de componente BIN (1ª Pesada) Resto pesadas BIN Armario o Pesada pico BIN Pesada en BINPesada en Envase Báscula 2, Pesada no aceptada BIN y Pesada en Envase A partir de la segunda pesada de la misma paleta Primera pesada, cambio de paleta o reanudación Quedan pesadas por realizar Según procedimiento Identificación de Bulto Pesado Synoptic graphs Material Safety Data Scale SOP Production Report Samples to laboratoryQA Analysis Lot preparation at production module level
  • 11 Documents used or generated in the production module: 1. Weight and dispense order report, 2. Material in box container roadmap, 3. Material in BIN container roadmap, 4. Module room cleaning Standard Operating Procedure (SOP), 5. Module tasks logbook, 6. Guide of operations of manufacturing workorder in the module, 7. Set-up, configuration and cleaning SOP for equipment and tools. 8. Synoptic graphs of equipment and accessories. 9. Material safety data specifications, 10. Test of samples for in-process control SOP, 11. Scale standardization and operation instructions, 12. Sample collection for analysis in QA laboratory and for mandatory storage of lot samples. Information at production module level
  • 12 1. Traditional manufacturing operative in question 2. Common manufacturing guide context 3. Implementation of a Manufacturing eGuide 4. Resources to use & how to make MeG real. 5. Almirall’s way to operations excellence 6. Continuous improvement … 7. Questions & answers. Improving operations performance through eGuides
  • 13 The “electronic” guide of Manufacturing operations is based on moving from the shape of the “traditional” manufacturing guide of a product or recipe on paper, to an interactive information technology system with the conversion of contents and documents in digital data and files, interrelated in a plant operations model. + MeG Implementation of a Manufacturing eGuide
  • 14 + Added value: • Verification of manual data entry for reliability, • Centralized access to documents related to MeG, • Secure access to functions and assets, • Lifecycle management of eGuides with version control from edition to approval, • Electronic signature to certify critical operations, • Historical data log records protected, • Audit trail of data changes in regulatory records, • Advanced reporting of genealogy and traceability. MeG Implementation of a Manufacturing eGuide
  • 15 1. Traditional manufacturing operative in question 2. Common manufacturing guide context 3. Implementation of a Manufacturing eGuide 4. Resources to use & how to make MeG real. 5. Almirall’s way to operations excellence 6. Continuous improvement … 7. Questions & answers. Improving operations performance through eGuides
  • 16 1. Definition and approval of a eGuide. 2. Plan and assign a Guide to a work order for a product or recipe. 3. Execute the operations of work order. 4. Track and analyze the activity and results. Audit the manufacturing process. The fundamental process of the manufacturing guides is: 1 2 3 4 Resources to use & how to make MeG real.
  • 17 • Step by step definition of operator actions inside the eGuide. • Modeling of production processes and routes of the plant. • Specific instructions for any process, product/recipe and manufacturing route. • Assignment of standard steps and actions to define each operation behavior: • Instructions and check-lists, • Operator confirmation of execution, • Operators single or multiple electronic signatures, • Manual data entry, • Process attributes or parameters registration. eGuide & Recipe Management Definition and approval of a eGuide
  • 18 Plant operations modelling in the MeG, examples
  • 19 • Work Order creation for product or recipe assigning an approved eGuide. • Work Order release assigning a route of a specific line or process. • Tracking the status of current orders and operations. • Order management to change priorities, suspend, release, sequence, close or cancel. WORK ORDER SCHEDULING Plan and assign a Guide to a work order
  • 20 • Operations execution and steps data entry. • Record lot of items/materials consummed and produced in the operation based on bill of material. • Record of process events and exceptions. • In-Process Control data entry for process statistical analysis and product quality control. • Display required SOP documents. Access to additional files in folders during execution. • Critical operations certification including electronic signature. PRODUCTION & CONDITIONING OPERATOR Execute the operations of work order.
  • 21 Supervisor Conditioning process Operation 100 Blistering Operation 200 Cartoning Operation 300 Packing Operator Work Order WO - 1 Operation 100 Blistering ready Operation 200 Cartoning pending Operation 300 Packing pending WO-1 Blistering running Blistering completed Cartoning ready Cartoning running Cartoning completed Packing ready Plant operations modelling in the MeG, an example
  • 22 eGuide operator interfase, examples
  • 23 • Support during execution of manufacturing orders. • Manufacturing order tracking. • Review of Production data and results. • Verification and acceptance of incidences. • eGuide final report approval. • Order release to next process. PRODUCTION SUPERVISION Track and analyze the activity and results
  • 24 1. Traditional manufacturing operative in question 2. Common manufacturing guide context 3. Implementation of a Manufacturing eGuide 4. Resources to use & how to make MeG real? 5. Almirall’s way to operations excellence 6. Continuous improvement … 7. Questions & answers. Improving operations performance through eGuides
  • 25 Almirall’s mission To provide society with innovative medicines that help to improve people’s health and quality of life.
  • 26 Almirall’s centres Headquarters: R&D Centers: Chemical plants: Pharmaceutical plants: Affiliates: • Barcelona • Sant Feliu de Llobregat • Bad Homburg (Germany) • Reinbek (Germany) • Chemical Synthesis Unit in Sant Just Desvern • Active Ingredient Scaling-up Unit in Sant Andreu de la Barca • Sant Andreu de la Barca • Sant Celoni • Sant Andreu de la Barca • Sant Just Desvern • Reinbek (Germany) • Austria, Belgium, France, Germany, Italy, Mexico, Poland, Portugal, Spain, Switzerland and the United Kingdom- Ireland.
  • 27 Almirall’s figures • 239 pharmaceutical specialties (*) • 543 presentations (*) • 57 countries • 89.3 million units of finished product • 3.5 million units in bulk (**) Third parties included
  • 28 Scope of implementation in Sant Andreu plant • 3 QC/Sampling cabins • 5 Weigh&Dispense cabins • 3 Liquid formulation modules • 3 Solid formulation modules • 6 Doses production modules
  • 29 Recipe Edition and Management • Weigh, formulation and dispensing recipe edition. • Paperless manufacturing guide implementation. • General Unit Procedure. • Bill of Equipment (BOE). • Use of action list with steps – Instructions with check-in lists. – Signatures (initial, single, double) – eDocuments: Standard operation procedures (SOP), material safety data sheets (MSDS), process synoptic graphs and other specs. • Recipe review and approval cycle.
  • 30 Manufacturing Orders Scheduling • Orders are released from the ERP based on plant capacity. • Automatic generation of mfgt. orders in the POMS MES system. • Batch generation for weight, liquid formulation, solid formulation and solid dosing operations. • Assignment of related process unit. • Exception monitoring. • Procedure traceability.
  • 31 Solids Formulation Operation • 2 formulation lines: dryer line and mixer line. • Combined or separated operation. • Manufacturing eGuide by actions • Check-in process unit and assets. • Registration of raw material and WIP containers. • Minor raw materials preparation in auxiliary tank. • Cleaning control of cabin & assets. • Automated BIN movement control. • Formulation batch report.
  • 32 Solids Dosing Operation • 6 dosing lines: tablets, capsules and sachets. • Manufacturing eGuide with process synoptic and product specs. • Check-in process unit and assets. • Registration of conditioning material and empty drum carriers. • Units registration of bags and drums with barcode labels. • Control of dose weigh. • Waste reporting and mass yield calculation of batch. • Dosing batch report.
  • 33 Production supervision • Support during execution of manufacturing orders. • Exception management. • Review of Production reports. • Verification and acceptance of incidences. • Production report approval. • Order / Batch release to next step.
  • 34 • Technological infrastructure update (equipment, hardware & software) • Standard life sciences MES package but customizations required • Logistics System integration. • Minimal interferences with plant production planning. • System Qualification and Validation for regulatory compliance. • External plant personnel. • Communication with legacy equipments, systems and installations. • International supplier with a recently new local integrator. • Standardization and homogenization of the system among the processes. • Project scope spitted in 3 phases for shorter milestones, visible results: (1º) QC / Sampling, (2º) Weigh & Dispense, (3º) Formulation and Dosing. • Specialized consultancy: intensive work vs constant work, consultancy costs vs training costs. • Evaluation of the real effort with an assumable planning for everybody. • Creation of a multidisciplinary human team for the project. • Certified technical training and practical learning by doing. • Analysis of requirements in depth. • Realignment with the standard MES product functionality to reduce customizations. Challenges and solutions
  • 35 1. Traditional manufacturing operative in question 2. Common manufacturing guide context 3. Implementation of a Manufacturing eGuide 4. Who & how make MeG real? 5. Almirall’s way to operations excellence 6. Continuous improvement … 7. Questions & answers. Improving operations performance through eGuides
  • 36 • for the definition: • Assets specifications, set-up instructions and parametrization. • Shopfloor devices & equipment interface (for automated plant data collection, conection to field instrumentation, etc.). • for scheduling: • ERP system interface of work order, inventory, reporting material quantities of production, consumption and scrapts. • for execution: • Data entry of production, consumption and scrapts of material. • Asset set-up based on specifications. • Automated plant data collection for step action and data logging. • for analysis: • Raw material lot traceability during operations (work in process). • Product genealogy, Inventory reports, Work order event logs. • Audit trail reporting. Continuous improvement ... enhanced functionality
  • 37 • Common model and services available • Modular and scalable system’s architecture Using • Dynamic order priority and route sequencing • Human resources tasks management • Shopfloor interface to equipment and HMI. Using • Real time inventory management • Definition of materials, substitutes y secondary prod. • Bill of Material (BOM) Using • Manufacturing centralized model • Implementation of Standard Operational Procedures • Certification of critical events Using • Current Work Order in process management • Production events recording Using Current production vs. plan compliance Process and production consistency improvement Inventory performance improvement Order “Lead Time” reduction Using an incremental approach to the operational improvement Continuous improvement ... bigger scope
  • 38 • ANSI/ISA-95: Enterprise-Control System Integration. • GAMP5: Good Automated Manufacturing Practice. Guide for Validation of Automated System. • CFR Title 21 FDA Part 11 – Electronic Records; Electronic Signatures (USA CFR regulation). • Guidance for Industry Parte 11, Electronic Records; Electronic Signatures – Scope and Application (August 2003). • Risk Based Approach to Compliant Electronic Records and Signatures (ISPE, October 2005). Continuous improvement ... regulatory compliance
  • 39 The manufacturing operations eGuide is a key to success of plant continuous improvement strategies, helping in the daily tasks of all human resources responsible for manufacturing, sharing essential information across plant areas and enabling regulatory compliance. The IT “facilitator” of plant human resources MeG
  • 40 1. Traditional manufacturing operative in question 2. Common manufacturing guide context 3. Implementation of a Manufacturing eGuide 4. Who & how make MeG real? 5. Continuous improvement … 6. Almirall’s way to operations excellence 7. Questions & answers. Improving operations performance through eGuides
  • 41 INLEAN C/ Jordi Girona, 1-3, Parc UPC – K2M 08034 Barcelona, SPAIN Tel. +34 93 494 1411 www.inlean.com linkedin.com/in/davidbadia twitter.com/davidbadia david.badia@inlean.com David Badia Improving operations performance through eGuides Thank you!