Cómo integrar el ERP corporativo con aplicaciones MES para Batch Record Electrónico y Data Integrity ETIF 2016

Transcription

1 Cómo integrar el ERP corporativo con aplicaciones MES para Batch Record Electrónico y Data Integrity ETIF 2016

2 Contents BATCH RECORD Guide Line for Preparation Revision Approval Filling Checking According to GMP Gilberto Rossi e Sergio Fasana 2

3 Disclaimer Into following slides may appear pharmaceutical products or raw material brands, due to the demo environment None of the data that could be showed has any validity but are only related to the scope of the demo, to explain how the package is working

4 Master Batch Record: PREPARATION A UNIQUE «DOCUMENT» controlled by the system Structured PREAPARATION of the Master Document Average in Compilation, thanks to standards objects like work cycle, process parameters, line s equipment, mobile equipment, working & safety instructions, note Operating Instructions Archive, validity check, link to stored SOP Safety Instruction Archive (chemical) Controlled Work Flow - Creation, Modification, Block, Approval «Frozen» workflow during modification Automatic Versioning Possibility to use ES for Batch Release (CFR 21 P.11) Automatic Alignment between MBR and BR: the DOCUMENT is prepared and issues by a VALIDATED SYSTEM MBR Validity MANAGEMENT (Operating Workflows closure date) A UNIQUE document for all steps, including and linking all item in one (e.g.: WO, BOM and PO)

5 Master Batch Record: PREPARATION Productive Process «Consistency Warranty» Single Components dosing indication & control, for each process step, starting from DISPENSING Identify each raw material using Pharmacopeia definition Batch Size based SCRAP prediction (and based on different machine capability) Use of raw materials considering TITLE and RANGE of compensation (instruments error not predictable) Automatic Calculation of Compensation Batch Size Re-Scaling based on raw material availability Optimised Creation of Master Batch Record Re-use of common instruction/operation Operating and Safety Instruction Archive, Technical Specification archive, versioning check MBR have to incorporate the real process, using variables which allows the description of the various working centre (e.g.: production equipment capability and availability) Working Time Equipment Point of Load and Loading Parameters Working Parameters Set Point and Data Collection Sampling Plan for intermediates and finished Product based on production quantity and frequency

6 Batch Record: Assembling & Printing Report From paper MBR to Electronic MBR Generation of Batch Record from the MBR Printing Batch Record with the following automatisms: System controlled Emission of BR, variable data collected ELECTRONICALLY Automatic alignment with correct version of packaging material Into the intermediate phase, prior the ebr, supported by paper: Step Bar-code instruction for each line of process DMS function allowing printed document support: Images, packaging instruction, data Collection Forms, etc. Controlled Printout Function (Audit trail &/or water marking) Versioning control: current BR comes from last approved version of MBR MRP based on date of entry to force of MBR (Versioning) Possible to produce Dept. Specific Datasheet Manipulating & Picking instruction for hazardous material (e.g.: Warning, dangerousness, Hot Chamber,.) List and Status of Mobile Equipment (Bins, filters, etc.)

7 Batch Record: a UNIQUE controlled document MBR BR Status MBR

8 Steps from BR to ebr STEP1: Pre-requisites Logistics function on Portable Terminal with bar-code reader Harmonised Labelling, from raw material loading, using DATA MATRIX Double coding for Raw Material (Supplier & Internal) Harmonised Label from minimal UDC (Loading/Handling Unit) to pallet Warehouse Bay Mapping Data Matrix to identify Warehouse cells and bay Controlled harmonised location (e.g. Chilled, Drugs, Flammable etc.) Identification of stock entry Sample point/room identification Warehouse Management (with optimised paths) Production buffer/stock management Weighing rooms management

9 Steps from BR to ebr Phase 1 1) Supply Production Lines and Weighing Rooms FIFO o FEFO Batch Management Management of Handling volume according to production requirements and loading units (Balancing of Quantity according to TITRATION) Recording of transfer between stock and production and between stock and weighing rooms (Origin Warehouse, Article, Batch, Handling Unit, Target Warehouse/Buffer, Operator, Time) Production Line pre-defined feeding, real time record time stamp 2) Production & Weighing rooms Real-Time-Final-Summary (final accounting) Weighing room and on production line operations traced by the system., including transfer of goods between depts. Just an operator is required for weight operation (except witness for drugs) Calculation by the System for the quantity of titrated components used for each batch NO manual intervention on the Batch Record Elimination of double weighing (Weighing Rooms & Production Line) Control of calibration and verification of weighing tolerance - Protocol and balance record of used scales Unique-Unambiguous labelling of weighed packages with evidence of any hazard symbols Production Line Delivery Check Final accounting of materials load to the system using laser scanners NO BR manual transcription required Additives weighing - Automatic Reformulation for weighing errors - Deviation Control Control of status and expiration date of the goods to at weighing Load control system (Holding time)

10 Steps from BR to ebr Phase 1 3) Final Accounting transfer from Production using laser readers and mobile client Intermediate transfer (stock transfer) data acquired form scales &/or from laser reader Yield Real Time Control Status Definition: NO Controlled CONTROLLED but non-blocking (Exception) the summary of checks along the line will define Batch Status LOCKED NOT Available until analytical results 4) Upload of Finished Products Final labelling and possibility of immediate trans-shipment warehouse Finished Product Serialization Labelling for Uncompleted Handling Unit Production Yield final control

11 Steps from BR to ebr Phase 2 1) Mobile Equipment Definition of availability of Mobile Equipment and Components using cleaning status Pre-defined/Guided Production Line Feeding, real time stamp tracking 2) Product s IPC - System automatic records Definition of Frequency of controls Controls Results acquisition from the equipment (Thermo-scales, scale, auto tester, electronic calibres, etc.) Process IPC Calibration IPC Definition of possible repetition intervals (out of T1 / within T2) Definition of Deviation Opening (out of T2) 3) Process Time Process Results Registration Manual and Automatic Registration with Portable Client and Laser Reader of Process Time & Results: Phase Operator Job Duration Time of registration

12 Steps from BR to ebr Phase 3 1) Field Process Parameters Acquisition Interface with Machine s ON Board Controller systems &/or On-Board SCADA for Process Parameter data collection Real time parameters checking and Deviation Control / Opening (EDM)

13 Steps from BR to ebr Phase 4 1) Environmental control parameters acquisition (production class c / b / a) Accessing and Collecting Data from Environmental Control System Particle Counter Environment Temperature Humidity Pressure Etc.

14 ebr - EXEPTION BATCH REVIEW Time Deviation Control Quantity Deviation Control Check Deviation Opening Process Corrctness Yield Calculation «Qualitative» Status Control Use of Raw Material & Material Exception Control IPC Analysis PQR Data Archiving Possibility of Economic final accounting

15 Batch Records Contents Batch Record HEADING: Product, Approval Work-Flow-Status, Batch Size (& possible Vairiation), Version Process / Production Line Mapping Work-Centers Defintion, Equipment, Internal Warehouses & Buffer, At Machine Control, throughput time Environment Status, Cleaning OPerations, Environmental Controls, Equipment Maintenance Status OPERATIONS Loading Sequences & Picking Criteria Internediate DIscharge Operating Instruction (SOPs) Safety Instruction Note SOP Process Parameter Formulation Units Weighing Units, Mode, Tollerance Restore to Titre SCRAPS MNGMT. IPC

16 Batch Record: Electronic Management Approval Work-Flow Management Master Batch Record Electronic Signature and Access Right Configuration (ES Automatic Pop-UP) Controlled Access Right Configuration Matrix Automatic Double Check request rights configuration USER ACCESS RIGH CHECK

17 Batch Record: Supply Chain Integrated Management Supplier Check Version Check

18 Batch Record: Electronic Management Historicizing MBR Audit trail Versioning Version Comparison Comments (Cause) of Variation

19 Batch record: Process/Product Components Identification Sequence Identification Formulation Units Line Feeding Units Quantity (based on Title) Analysis (Title) Teorethical Title & Restore to Titre Weighing Mode Weighing Tollerace

20 Batch Record: Process Control Defining the precise amount for each load Point of Feed/Load identification (line buffer) Internal «Path of Feeding» Real Time Production Capability and Availability overview Real time check for Quality Code and Expiration Time

21 Batch Record: Process Control PlANNING QUALITY STATUS LABELLING

22 Batch record : Components Control Titration parameters in MBR Theoretical Title calculation and indication of the AS-IS Quantity Titre Parameters UNIT identification (%Weigh, UI, UFC) Defintion of the Return-to-Titre limts to avoid COMPENSATION (within measuring range) Compensation Substances Definition Possibility of Exclusion of Compensation Substances (e.g.: Antibioticos Dosing into VIAL)

23 Batch record : Components Control Batch Title (97,6) Ware-House Re-Calculation Weighing Room Re-Calculation

24 Batch Record: Process Control Weighing Opration Set-Point Fixing (Locking) Weighin Tolerances Automatic Identification of the first available scale (status based) Forcing Weighing s Unit Weighing Operation Time & Resources Reduction (1 Operator) Re-calculation and deviation management for multiple weighs MBR Weighing Parameters

25 Batch Record: Operations & Controls Operations Single Operation Time and Final Accounting Management Formules Standardized Time (cleaning, set up machines ) Batch Standardized phase-time (e.g.: granulation time) Variable Time Management (e.g.: material loads into equioment, ) Time collection to be used for production capability analysis Single Operation Standardization Automatic Availability of Operating Instruction for each Step IS standard from Archive Each Operation has a pre-determined cost

26 Batch record: OI/IS Operating Instruction Standardization Operating Instruction Standardization MBR Versioning Control locked during variation Forcing Standardization from first imput, which means more time to prepare but extremily higher flexibility during use: Eg. Mix cleaning will be allways the same; Powder Weighing time will be allways the same Extrapolation and time management of Process Parameters; Es. riscaldare alla temperatura indicata (IO Generale) Parametro di processo 60 +/- 3 C Simplified preparation, replacement and copy of Master Batch Change Time reduction Lock-out of MBR (during variation)

27 Batch Record : OI/IS Operating Instruction Standardization Standardization of Safety Instructions Link to the Primary Article to Highlight Hazardous Raw Material indications Option: Importing of Hazardous Data from external SW (Envicon) Highlight of each Manpulation nstruction, from Weighing Operation to Production OI STandardization Automatic Assignemt of Resources &/or Operations Hazardous Article Notes and OI updtaes & replacement MBR Update mechanism, with automatic lock function in case of variation

28 Batch Record: OI/IS Operating Instruction Standardization Formule Mngmt MBR

29 Scheduling for Dept., Logistics, Equipment BR Organization for Production Dept. A unique Batch Record for the Preparation Mixing Ganulation Drying Compression Coating RAW Material & Packaging Material Delivery Point Definition Defintion of Dept. Buffer Dept Access Control / Equipment Set Point Cross & Throuput Time Defintion Equipment / Production Line / Dept. Identification Line Equipment and Mobile Equipment Batch Record Head Summary for Start-Check Mobile Equipment & Components (Tabletting Tools, tank, etc.) managed by tool/equipment S/N Cleaning Status Mngmt.

30 Batch Record: IPC Collection Identifcation of Line Checks Control Standardization (Archive) Line Controls & Analytical Controls Blocking-Results defintion Archive Historicisation Statical Analysis of Results FORMULA MBR

31 Batch Record: IPC Control Specification Controls Specification Single Controls Definition Analytical Methods Link 31

32 Batch Record: IPC Control Plan Head of a Test Plan Test Plan Management Each test Plan contains controls list, limits, tolerances

33 Batch Record: IPC Raws Control Test Plan RAWs Single Test Definition, details of Sampling Type, Analysis type and Method, expected results, limits & Tolerances

34 Batch Record: IPC Control Plan Assignment Test Plan Assignment The Test Plan will be assigned to a Receipt/Formula, and to the Output Resource

35 Batch Record: IPC Data Collection Data Collection Example of Data Collection during Production

36 Thank you for your attention! Questions? Gilberto Rossi Latino America Consultores Sergio Fasana Eon Srl

37 Cómo integrar el ERP corporativo con aplicaciones MES para Batch Record Electrónico y Data Integrity ETIF 2016