CTP Tecnologie di Processo è un’azienda certificata:
CONTRACT MANUFACTURING EVOLUTION
CTP Tecnologie di Processo è un’azienda certificata:
CTP Tecnologie di Processo
CONTRACT MANUFACTURING EVOLUTION
Schema relazione
I.
La motivazione
II. L’analisi e le scelte
III. Gli strumenti
CONTRACT MANUFACTURING EVOLUTION
I. La motivazione
La situazione mondiale, le strategie del futuro
CONTRACT MANUFACTURING EVOLUTION
La motivazione
RANKING BY ETHICAL DRUG SALES - 1981 Vs 2001
1981
2001
CONTRACT MANUFACTURING EVOLUTION
La motivazione
THE BLOCKBUSTER MODEL
CONTRACT MANUFACTURING EVOLUTION
La motivazione
R&D cost, Dev.times, NME output and Sales world growth from 1993 to 2003
R&D Expenditure
Development times NME output
Sales
200
180
160
140
120
100
80
60
0000 0000 0000 1997 1998 1999 2000 2001 2002 2003 Year
Index
CONTRACT MANUFACTURING EVOLUTION La motivazione Table 1: The leading pharmaceutical companies will lose between 14% and 41% of their existing revenues as a result of patent expires | |||||||||
Company | 2010 | 2011 | 2012 | Share of Revenues (%) | |||||
AstraZeneca | Arimidex | $2.2bn | Seroquel | $4.7bn | Symbicort | $3.7bn | 38 | ||
BMS | US Plavix | $4.8bn | Abilify | $2.1bn | 30 | ||||
Avapro | $1.3bn | ||||||||
GSK | Advair | $3.8bn | Avandia | $2.5bn | 23 | ||||
Xxx Xxxxx | Zyprexa | $4.8bn | 22 | ||||||
Merck | Cozaar/ Hyzaar | $3.2bn | Singulair | $4.5bn | 22 | ||||
Novartis | Femara | $1.1bn | Diovan | $6.0bn | 14 | ||||
Pfizer | Aricept | $800m | Lipitor | $12.1bn | Viagra | $4.5bn | 41 | ||
Xalatan | $1.6bn | Detrol | $860m | ||||||
Geodon | $1.1bn | ||||||||
Sanofi-Aventis | Taxotere | $2bn | US Plavix | $3.8bn | Lovenox | $3.1bn | 34 | ||
Avapro | $2.1bn | ||||||||
CONTRACT MANUFACTURING EVOLUTION
La motivazione
Dry pharma pipelines
Globalization
Increasing competition for in-licensing
Focus
Price pressure from healthcare systems
Increasing shift from Rx to Gx
•Innovation and product introduction no longer affordable at country/region level
•Leaders positioned in all key countries with globally designed business systems
•All major pharmacos want to move to a few attractive (high-volume, high-growth, high barriers to entry) therapeutic areas
•Ongoing industry consolidation Consolidation •Emergence of large global pharma
players with potential scale advantages in M&S, X&X, and Operations
CONTRACT MANUFACTURING EVOLUTION
La motivazione
CAPACITY UTILIZATION*, 2002
Percent
100%
ROUGH ESTIMATES BASED
ON SITE VISITS**
Unused capacity
-65%
-56%
-73%
-69%
53%**
There are significant excess capacities
Assuming 5 x 2 shifts
Solids Liquids Solids Liquids formulation formulation packaging packaging
* Defined as actual output divided by output of machine running at technical limit during full shift time
** Capacity utilization calculated as machine utilization time divided by maximum running time adapted to 5 x 2 shifts
CONTRACT MANUFACTURING EVOLUTION
La motivazione
CAPEX DEVELOPMENT FOR MAINTENANCE
EUR millions
13% CAGR for CapEx maintenance versus
1% CAGR for production volume
~ 88
~ 61
Due to network and production fragmenta- tion, CapEx dedicated to network maintenance has grown significantly
~ 35
~ 41
~ 25
~ 29
Production volume
PU, millions
1994
1996 1998 2000 2002 2004
626
717
CONTRACT MANUFACTURING EVOLUTION
La motivazione
2013: LA GRANDE GLACIAZIONE
Evoluzione fatturato Industria Farmaceutica Internazionale
2007 2008 2009 2010 2011 2012 2013 2014 2015
CONTRACT MANUFACTURING EVOLUTION
La motivazione
ASPIRATIONS FOR NETWORK REORGANIZATION
From To
• Fragmented network • Stable and flexible network with strong launch capabilities
• Complex product portfolio • Production of rewarded
complexity only
• Underutilized capacities across • Appropriate capacity utilization sites and technologies of all technologies
1
Launch sites
CONTRACT MANUFACTURING EVOLUTION
TYPES OF SITES IN FUTURE NETWORK
• Global/regional launch of products
• Guarantee smooth product launch
• Preservation and further development of know-how and expertise for key technologies (including new technologies)
2
Key market presence and ongoing supply
• Focus on continuous, reliable low-cost supply
• Production of mature products
• Possible differentiation
– Large vs. small products
– Rx/OTC vs. Natural Health
3
Competence centers for specific technologies
• Global competence center for selected technologies
• Product launch and ongoing supply combined on-site
• Potential key technologies (es.)
– Respiratory drugs and devices
– Sterile application forms
CONTRACT MANUFACTURING EVOLUTION
NETWORK STRATEGIES OF MAIN COMPANIES – EXAMPLES
Abbott AZ BMS
GSK
J&J
Novartis
• Cost focus (improvement in individual plants, benchmarking)
• Development of launch site
• Network optimization
• Second round of network optimization
• Multiple productivity and quality improvements per plant
• Network optimization and regionalization of Ops responsibility
• Process excellence/lean manufacturing
• Aggressive plant network optimization and coherent supply chain setup to capture lowest possible COGS
– A few plants focused by forms and volumes
– Launch sites
– Truly global Ops responsibility and stringent SCM processes
Novo-Nordisk
• Application of lean manufacturing across all plants to free up capacity, limit investments, and reduce costs
Pfizer Roche
Warner- Xxxxxxx
• Focus plant distinctiveness (lean)
• Cost focus (plant network, investments)
• Launch capabilities (to some extent forced by Xenical)
• Development of launch site
CONTRACT MANUFACTURING EVOLUTION
II. L’analisi e le scelte
Scegliere la strategia, analizzare l’impatto e implementare i migliorament
CONTRACT MANUFACTURING EVOLUTION
L’analisi e le scelte
IMPROVEMENT IN MANAGEMENT SYSTEMS AND BUSINESS PROCESSES
Efficient and fully integrated
management systems
•Consolidate and streamline management meeting landscape to two key meetings
•Consolidate current fragmented planning tools in one central fact base for key decisions
Business process excellence
CIVISO
•Develop new processes for
– Third‐party management
– Global network coordination (product/volume allocation)
– Best practice transfer (benchmarking)
•Optimize existing processes
– Annual discussion
– Global asset management (corporate invest process)
– Personnel development
QbD
CONTRACT MANUFACTURING EVOLUTION
L’analisi e le scelte
Possibili approcci al contract manufacturing
CONTRACT MANUFACTURING EVOLUTION
L’analisi e le scelte
CSO
Contract Support Organization
+ CMO
Contract Manufacturing Organization
Integrazione di un processo frammentato
CMSO
Contract Manufacturing and Support Organization
Single-source provider from manufacturing through commercial manufacture
CONTRACT MANUFACTURING EVOLUTION
L’analisi e le scelte
CMSO
Contract Manufacturing and Support Organization
Analytical development and validation
Industrial productions
Formulation development
Dossier writing
Client idea Generic product
Client product
Process development
Raw materials sourcing
Pilot batches
Production for clinical trials
Stability studies
CONTRACT MANUFACTURING EVOLUTION
L’analisi e le scelte
CMSO NEEDS
CTP SUPPORT
Industrial productions
Formulation development
CMSO LIFE CYCLE
CTP SYSTEM NTEGRATED COMPETENCE
Process development
Pilot batches
Production for clinical trials
Analytical development
and validation
Dossier writing
Stability studies
Raw materials
sourcing
CONTRACT MANUFACTURING EVOLUTION
L’analisi e le scelte
Passare da un concetto di PRODOTTO ad un concetto di SERVIZIO
Quello che per noi è normale attività per gli altri è un PROBLEMA Ciò che per gli altri è un PROBLEMA per VOI deve essere un BUSINESS
Diventare partner STRATEGICI e non solo TATTICI
CLIENTI TARGET
✓ Piccole e Medie Aziende prevalentemente commerciali magari senza stabilimento produttivo
✓ Grandi Aziende che vogliono delocalizzare produzioni mature o di nicchia
CONTRACT MANUFACTURING EVOLUTION
L’analisi e le scelte
Excelvision, Xxxxxxx, Xxxxxx Xxxxxx, Xxxxxxxxx, XXXX, Xxxxxxx, Xxxxxxxx, XXX, Xxxxxxxxxx, Vianex, Holopack, Catalent, Montefarmaco, Nycomed, PharmaSter, Wockhardt, Patheon, Fareva, Xxxxx, Abbott, FDC-India, Promed, Etc ……
Il mercato dei terzisti è un mercato altamente competitivo
CONTRACT MANUFACTURING EVOLUTION
L’analisi e le scelte
Il mercato dei terzisti è un mercato altamente competitivo
WHY MOVING PRODUCTS?
GENERAL
⮚ Market changes
⮚ Product life cycles
⮚ Optimizing production between locations
⮚ Mergers & Acquisitions
ECONOMIC
⮚ International cost competition
⮚ Tax advantages
⮚ Supply Chain rationalization
SEARCH FOR PRODUCTION EFFECTIVENESS
CONTRACT MANUFACTURING EVOLUTION
L’analisi e le scelte
IDENTIFIED IMPROVEMENT MEASURES
Process
Development
Transfer
Life cycle optimization
I M P R O V E M E N T
1
Dedicated process engineering function at launch site
2
3
M E A S U R E S
Own global standards for excipients, materials, and other elements
4
Cross-functional alignment and management
Defined quality xxxxx (acceptance criteria) for development process
CONTRACT MANUFACTURING EVOLUTION
III. Gli strumenti
Xxxxxxxx e criticità di alcune scelte.
Quali sono e come usare gli strumenti di analisi.
CONTRACT MANUFACTURING EVOLUTION
Gli strumenti
TERZIARIZZAZIONE DELLA PRODUZIONE DEL FARMACO NEI PAESI EXTRA E.U.
Paesi Low Cost
Esclusione dei Paesi:
Usa Canada Australia Islanda Giappone
Paesi consolidati: Turchia India
Cina
Paesi emergenti: Vietnam Tunisia Marocco Algeria Sud Xxxxx
CONTRACT MANUFACTURING EVOLUTION
Gli strumenti
I. VERIFICA REGOLATORIA
Stato autorizzazioni, gap analysis, integrazioni per importazioni
II. VERIFICA LOGISTICA
Supply chain
III. VALUTAZIONE ECONOMICA
Costi fissi, addizionali e variabili
CONTRACT MANUFACTURING EVOLUTION
Gli strumenti
VALUTAZIONE ECONOMICA
COSTI ADDIZIONALI
COSTI VARIABILI
• Costo convalida interna produttiva/analitica
• Costo di convalida analitica per il rilascio del prodotto
• Costo stabilità on-going e PQR
• Costo mantenimento certificazione EU
• Costo qualifica interna supply chain
• Costo di adattamento impianti (eventuali)
COSTI FISSI
• Costo A.P.I.
• Costo service
• Costo Materie Prime
• Costo materiali di confezionamento
• Costo trasporto
• Costo di release
• Costo adattamento prodotto requisiti nazionali
• Costo per risk analysis prodotto
• Costo mantenimento progetto
• Costo derivante dalla riserva di sicurezza del prodotto
• Costo derivante dalle fluttuazioni monetarie
CONTRACT MANUFACTURING EVOLUTION
Gli strumenti
PRODUCT TECHNOLOGY TRANSFER
Come dare un servizio, fare business ed evitare ritardi nello start up produttivo
CONTRACT MANUFACTURING EVOLUTION
Gli strumenti
THE MAJOR OBSTACLES
• No management of transfer / no project manager
• No consistent transfer team
• Regulatory requirements unclear
• Priority for production in the plant
• Ineffective communications between functions
• Poor definition of the target
• Industrial strategy unclear
• Process not transferable
• Vague definition of the tasks
• Cultural misunderstanding
• Unavailability of people
• Unrealistic timelines and lack of cost evaluation
• No integration of the receiving site expectations
• Lack of training
• …..
CONTRACT MANUFACTURING EVOLUTION
Gli strumenti
PRODUCT TRANSFER MATERIAL
•Transfer Standard
STANDARD
GUIDELINES
•Product transfer between manufacturing sites
•Analytical technology transfers between sites
STANDARD DOCUMENTS
•Pre-evaluation document
•Project Definition Document (PDD)
•Transfer Activity Monitoring Document (TAMD)
•Monthly report
SUPPORT DOCUMENTS
•Training material
CONTRACT MANUFACTURING EVOLUTION
Gli strumenti
GENERAL PROCESS FLOWCHART
Data collection for a first appraisal
Preliminary evaluation
Detailed evaluation
Document preparation
Regulatory Support
Protocols Materials Documentation
Validation activities
OPERATIONAL PHASE
Trial batches
PROJECT COMPLETION
qualification
and Process
Submission
CTP support
Agency review
Market approval(s)
Project Definition Document
PREPARATORY
PHASE
FEASIBILITY PHASE
PRE-EVALUATION PHASE
CONTRACT MANUFACTURING EVOLUTION
Gli strumenti
TRANSFER TEAM ORGANISATION
Donor site
Finance
Analytical Dev. &
Quality control
Quality Assurance
Equipment & Facilities
Manufacturing
Packaging & Artwork
Industrial Technology
Regulatory Affairs
Supply chain
CONTRACT MANUFACTURING EVOLUTION
Gli strumenti
THE PROJECT LEADER
• Expert named from CTP Team
• Leads a group of individuals from different functional areas (within receiving site but also from external) to develop and execute a strategy that delivers the business benefit
Project Leader
Planning
Leading
Organizing
Controlling
CONTRACT MANUFACTURING EVOLUTION
Gli strumenti
PLOC ACTIVITES AND DELIVERIES
▪ Define products to be transferred (formulations, packs, markets, volumes)
▪ Audit receiving site
▪ Establish current status for regulatory and quality issues
▪ Define process in receiving site
▪ Define regulatory strategy
▪ Define capital and revenue costs of implementation
▪ Define analytical methods transfer strategy
▪ Identify supply chain issues
▪ Establish project schedule
▪ Confirm project profitability
▪ Prepare documentation, SOPs, methods, equipment, …
CONTRACT MANUFACTURING EVOLUTION
Gli strumenti Assicurazione di Qualità
L’Assicurazione di Qualità
nella scelta e nella gestione delle attività in outsourcing
✓ Il processo di scelta di un possibile partner a cui affidare attività in outsourcing è un processo multifunzionale che deve essere gestito in accordo al Sistema di Qualità sia del Committente sia del Fabbricante.
• Customer Service e Production Service Level
• Scouting e auditing a fornitori
• Implementazione file o software per calcolo costi per offerte e verifica a consuntivo della redditività
• Implementazione Sistema QA per servizio al cliente (info su change, deviazioni, non conformità, ecc.)
• Adattamento del Regolatorio per supportare il cliente nelle attività regolatorie per il trasferimento della produzione e delle analisi relative
CONTRACT MANUFACTURING EVOLUTION
Gli strumenti Assicurazione di Qualità
In ambito farmaceutico, il processo di selezione di un partner per attività in outsourcing non solo deve tenere conto delle esigenze logistiche, economiche e/o di fornitura, ma deve anche ottemperare ai requisiti regolatori e GMP.
⮚ Capitolo 7 “Contract Manufacture and Analysis” – EU GMP
⮚ Capitolo 6 “Quality Control” – EU GMP
⮚ Annex 16 “Certification by a Qualified Person and Batch Release”
✓ Sviluppo o adattamento di struttura per contrattualistica e capitolati tecnici
CONTRACT MANUFACTURING EVOLUTION
Gli strumenti Ruolo QA
Technical Agreement
La sottoscrizione di un Technical Agreement tra le parti:
✓ Sancisce la conclusione del processo di selezione del partner esterno;
✓ E’ un elemento essenziale ed irrinunciabile per ottemperare agli obblighi normativi;
✓ E’ il documento essenziale e di riferimento per la gestione delle attività nel tempo;
✓ Deve essere redatto e sottoscritto tra le parti in modo da definire chiaramente, concordare e controllare le attività affidate a terzi;
✓ Deve essere redatto in modo da definire chiaramente le responsabilità delle parti:
• Acquisto materiali (reagenti, colonne, standard)
• Modalità di campionamento
• Invio e conservazione dei campioni di analisi
• Analisi (redazione ed approvazione metodiche e specifiche)
• Conservazione dei campioni d’archivio
• Conservazione dei dati analitici
• Rilascio (modalità di certificazione e rilascio)
• Modalità di gestione di OOS, deviazioni e change
• Modalità di gestione di difettosità e/o reclami
✓ Deve chiaramente indicare le modalità seguite nel rilascio dei lotti dalla QP
✓ Deve essere redatto da personale tecnicamente competente per quanto concerne gli aspetti tecnici sia tecnologici, sia analitici, sia GMP, sia legali
Technical Agreement
Il contesto normativo
✓ Codice civile
✓ Decreto legislativo 14.04.06 n. 219 – codice dei medicinali
✓ Legge 18.06.98 n. 192 – subfornitura
✓ Decreto legislativo 6.09.2005 n. 2006 – codice del consumo
CTP TECHNICAL AND LEGAL SUPPORT
CONTRACT MANUFACTURING EVOLUTION
Gli strumenti
“Quality by Design”
er migliorare il servizio al cliente e ridurre i cost
Quality by Design
Quality Risk Managemen
Track & Trending
DOCUMENT MANAGEMENT SYSTEM
CONTRACT MANUFACTURING EVOLUTION
Gli strumenti
Quality by Design Scope
The main problem is variability
Pharmaceutical Products are of good quality. Quality itself is not the issue, but pharmaceutical development and manufacturing could be improved because: Uncontrolled variability in e.g. properties of the starting materials or the manufacturing process affects the quality of the medicinal product.
CONTRACT MANUFACTURING EVOLUTION
Gli strumenti
Quality by Design Scope
How can variability be reduced?
By obtaining increased process and product understanding in order to identify and appropriately manage critical sources of variability and hence achieve “right first time” performance.
Need for a shift in paradigm:
From compliance
To enhanced product and process understanding
CONTRACT MANUFACTURING EVOLUTION
Gli strumenti
Quality by Design Scope
Desired state
• Product quality and performance achieved and assured by design of effective and efficient manufacturing processes
• Product specifications based on mechanistic understanding of how formulation and process factors impact product performance
• Continuous "real time" quality assurance
How to deliver the desired state?
▪ Invest in Pharmaceutical Development
▪ Identify critical material and process parameters affecting product quality (using prior knowledge, risk management tools, DOE, MVA)
▪ Understand and if possible express mathematically their relationship with the critical quality attributes
▪ Design a process measurement system to allow on-line or at-line monitoring of critical quality attributes
▪ Design a control system that will allow adjustment of critical quality attributes
▪ Implement a quality system that allows continuous improvement
CONTRACT MANUFACTURING EVOLUTION
Gli strumenti
Quality by Design ey Aspect
ICH Q8: Pharmaceutical Development
“Quality cannot be tested into products; quality should be
built in by design”
CONTRACT MANUFACTURING EVOLUTION
Gli strumenti
Quality by Design Applications
Pharmaceutical Development
- Systematic, establishment of design space
Manufacturing process
- Not set, but adjustable within design space
- Lifecycle approach to validation: continuous process verification, alternative strategies to the conventional 3 batches approach
Process controls
- PAT tools used with feed forward and feedback controls
Product specifications
- Based on desired product performance with relevant supportive data
Control strategy
- Quality controls shifted upstream. Possibility of real-time release or reduced end-product testing
CONTRACT MANUFACTURING EVOLUTION
Gli strumenti
Quality by Design Tools
Regulatory tools to support the Desired state
Quality Risk Management
Track & Trending
DOCUMENT MANAGEMENT SYSTEM
CONTRACT MANUFACTURING EVOLUTION
Gli strumenti
Quality Risk Management Process flow
Risk Assessment
What can go wrong?
✓ What is the likelihood (probability) it would go wrong?
✓ What are the consequences?
Risk analysis is a systematic use of information to identify specific sources of harm (hazards) and to estimate the risk.
Risk evaluation compares the estimated risk against given risk criteria using a quantitative or qualitative scale to determine the significance of the risk.
CONTRACT MANUFACTURING EVOLUTION
Gli strumenti
Quality Risk Management Applications
1. Development (e.g. Specification Setting, Test Method Selection and process development).
2. Regulatory scrutiny during pre and post approval.
3. As a component of Quality systems (e.g. Auditing, Deviations/Discrepancies, Complaints & Recall Management, Change management)
4. Facility systems management (e.g. Design, Hygiene, Qualification, environmental control, Preventative maintenance and Computerized systems)
5. Materials Management (e.g. Supply chain, Assessment and evaluation of suppliers and contract manufacturers, procurement and release of material)
6. Production (e.g. PAT, Validation, in-process sampling, testing, reporting and trending)
7. Laboratory controls (e.g. validation, testing, methods development, stability).
8. Packaging and labeling (e.g. Selection of container closure system and label controls).
9. Regulatory Authority Activities
CONTRACT MANUFACTURING EVOLUTION
Gli strumenti
Track & Trending Scope
Reference guideline: ICH Q10
✓ To use effective monitoring systems for process performance and product quality providing assurance of continued capability of processes.
✓ Identification and implementation of necessary product quality improvements, process improvements, variability reduction, innovations, and quality system tools, thereby increasing the ability to consistently fulfil quality and financial requirements. Risk Management techniques may be used to identify necessary areas for improvement.
CONTRACT MANUFACTURING EVOLUTION
Gli strumenti
Track & Trending pplication
Quality and financial tools
Annual Product Review
1.
2.
3.
5.
6.
7.
8.
9.
QA – QC Data Monitoring Process data Monitoring Engineering Data Monitoring Change Managing System CAPA Managing System KPIs System
Toll Manufacturing Price Evaluation
“Control panel”
❑Stream: Stock Reporting and Management
❑MonFor: Supplier Performance Monitor
❑Scheduler: Production Order Compiler
❑OrdProd: Efficiency in Production
CONTRACT MANUFACTURING EVOLUTION
Track & Trending Applications
5. KPIs system
Name
Definition
Qua- lity
Quality service level (QSL) Rate of justified complaints Accident frequency rate Capacity utilization
1 - (Rejected + reworked + reanalysed batches)/total batches (no. of total complaints)/(total PU produced)
(no. of severe accidents)/(total labor hours) (Running time)/8,760 hours
%
ppm Ppm
%
Capex maint./depr. wPCI*
(Capex for maintainance)/depreciations Development of production cost compared to base year, net of product mix changes
%
%
and inflation/devaluation
Cost
wMCI*
Development of material cost from 3rd parties compared to base year, net of product %
Yield**
Overall equipment effectiveness (OEE)
Turnover ratio forward (TRF)
mix changes
(Value of employed material in endproduct)/(total value of employed material) (Real running time)/(available capacity)
%
%
Production service level (PSL)
Intercompany service level (ISL)
Customer service level (CSL)
4 x (projected deliveries in month M+1, M+2 and M+3)/(total inventory at end of month M), deliveries/inventory valued at COG
Average of classified deviation in days for all items between requirement date and date of stock availability
(Number of correctly fulfilled intercompany order lines)/(total number of intercompany order lines)
–
%
%
(Number of correctly fulfilled customer order lines)/(total number of customer order
lines)
%
Time
CONTRACT MANUFACTURING EVOLUTION
Gli strumenti
Track & Trending Further development
Problem Analysis
▪ The Track and Trending activities will lead to the highlighting of the main problems affecting quality level, costs, deviations and complaints
▪ Once highlighted the main problems (i.e. yields, market complaints, assay uncontrolled trends, analytical failure investigations, on hold products, etc.) is suggested to put in place a “Pareto” analysis in order to set up priorities in the recovery plan
Problem solving
▪ Once given priorities and put in place a recovery plan is suggested to evaluate possible causes for each problem highlighted
▪ One possible approach is the “bone fish analysis”
▪ Is suggested to involve people of the department / s where the problem is supposed to come from
Track & Trending Further development Quality Output Standardization ▪ In every production plant, during normal production activities, could be highlighted some products with defects by automatic checkers or by production or analytical personnel. ▪ Once highlighted these defects is very important to have in place common and approved lists for defect evaluations in order to quickly give to the personnel a tool for checking and evaluating the problem and put in action a quick, shared and effective remediation activity including resampling or reworking. ▪ This would lead to a common “Quality Behaviour” in every plant of a multinational company, would reduce the on hold time and costs and would give to personnel a common “Quality Feeling”. | ||
Track & Trending Further development
Data Warehouse and Quality Compliance Assurance System
▪ Usually, in every company, there are software up and running; they are often customized for each department’s needs (AS400, SAP, LIMS, POMS, etc.)
▪ Very often these systems are not connected and lots of data in them have to be put in at least twice or extracted manually and managed with excel or access files.
▪ Is suggested to have a simple software that could link all the systems in place and extract data in order to have graphics, trends or highlight quality “alarms”
Track & Trending Further development
Data Warehouse and Quality Compliance Assurance System
EXAMPLE
✓ The QA-Process module contains two separate but integrated applications that can share data:
✓ QA Management Tool
✓ GMP Event Monitoring & Tracking of Identification , Recording and monitoring of process events
✓ Deviation Management
✓ Complaint Management
✓ CAPA Management
✓ Change Management
✓ MBR e EBR, Master Batch Record and Electronic Batch Record
✓ APR & QPR Annual & Quality Product Review
✓ GMP Production Tool s
✓ Management of Production , Materials and Service Level KPIs
“Executive Summary Slide”
DISPONIBILIDAD DEL MATERIAL DE LAS CONFERENCIAS
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