MES para Batch Record Electrónico y - … · Warehouse Bay Mapping ... Environment Temperature...

Cómo integrar el ERP corporativo con

aplicaciones

MES para Batch Record Electrónico y

Data IntegrityETIF 2016

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

Contents

2

BATCH RECORD Guide Line for

Preparation

Revision

Approval

Filling

Checking

According to GMP

Gilberto Rossi e Sergio Fasana


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


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)

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

Master Batch Record: PREPARATION


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.)

Batch Record: Assembling & Printing Report


Batch Record: a UNIQUE controlled document

MBRBR

Status MBR


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

Steps from BR to eBR – STEP1: Pre-requisites


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)

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



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



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)



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.



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

eBR - EXEPTION BATCH REVIEW


Batch RecordHEADING: 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

Operating Instruction

(SOPs)

Safety Instruction

Note SOPProcess

Parameter

Loading Sequences & Picking Criteria

FormulationUnits

Weighing Units,Mode,

Tollerance

Restore to Titre

SCRAPS MNGMT.

InternediateDIscharge

IPC

Batch Records Contents


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

Batch Record: Electronic Management

USER ACCESS

RIGH CHECK


Batch Record: Supply Chain Integrated Management

Supplier

Check

Version Check


Historicizing MBR Audit trail

Versioning

Version Comparison

Comments (Cause) of Variation

Batch Record: Electronic Management


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


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

Batch Record: Process Control



PlANNINGQUALITY STATUS

LABELLING


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)

Batch record : Components’ Control


Batch record : Components’ Control

Batch Title (97,6)

Ware-House Re-Calculation

Weighing Room Re-Calculation


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


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

Batch Record: Operations & Controls


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)

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

Batch Record : OI/IS Operating Instruction Standardization


Batch Record: OI/IS Operating Instruction Standardization

MBR

Formule Mngmt


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.

Scheduling for Dept., Logistics, Equipment


Identifcation of Line Checks Control Standardization (Archive)

Line Controls & Analytical Controls

Blocking-Results defintion

Archive Historicisation

Statical Analysis of Results

MBR

FORMULA

Batch Record: IPC Collection


31

Controls Specification

Single Controls Definition

Analytical Methods Link

Batch Record: IPC Control Specification


Head of a Test Plan

Test Plan Management

Each test Plan contains controls list, limits, tolerances

Batch Record: IPC Control Plan


Test Plan RAWs Single Test Definition, details of Sampling Type, Analysis type and Method, expected

results, limits & Tolerances

Batch Record: IPC Raws Control


Test Plan Assignment The Test Plan will be assigned to a Receipt/Formula, and to the Output Resource

Batch Record: IPC Control Plan Assignment


Data Collection – Example of Data Collection during Production

Batch Record: IPC Data Collection


Questions?

Gilberto Rossi Latino America Consultores

[email protected]

Sergio FasanaEon Srl

[email protected]

Thank you for your attention!


Cómo integrar el ERP

corporativo con

aplicaciones

MES para Batch Record

Electrónico y

Data Integrity

ETIF 2016

http://www.latconsultores.com.ar/novedades/Conferencias-ETIF-2016-id103.html

MES para Batch Record Electrónico y - … · Warehouse Bay Mapping ... Environment Temperature...

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