Pfizer Ispe

Aplicación de la
verificación según
ASTM E2500-07
Agenda
• Background
• Glossary
• Verification general concepts
• Changing Roles & Responsibilities
• Case Study – Pfizer Algete New PW Plant
• Verification implementation challenges
Background
Glossary
Verification general concepts
Changing Roles & Responsibilities
•Focused on
Product/Process and
Regulatory/PQS
•Requirements Requirements only
•Engineering Document for
User and other requirements
(I.e. EH&S)
•Verification Quality
Strategy: Top down
approach based on
Requirements Document and
design review
Verification •Testing is a single GEP

•Testing Testing activity – covering
commissioning, FAT, SAT &
IOQ
•Single close out report for

•Close-out IOQ Task system
Report(s) Reports
Changing Roles & Responsibilities
Areas of Opportunity within
Verification
#1 Flexibility and Scalability
Commissioning & Qualification (C&Q) #2 Leverage GEP & Subject Matter Experts (Less details)
#3 Leverage Supplier Documentation
#4 Avoid repetition of tests (Commissioning/IOQ)
#5 Reduce Periodic Review Scope
#6 Reduce number of docs retained etc.
#7 Targeted Critical Aspects of:
* Manufacturing Systems
(reduce site Critical components)
* Engineering Operations
Verification
* Cost improvements
In summary
Verification Process Model Overview
Verification Process Model Overview
Case Study
New PW plant
Pfizer Spain
Manufacturing Site
Case Study – New PW plant
• Case study
• New Purified Water generation plant and new Purified Water
distribution loop
• Project Scope
• Project driver: increase PW generation capacity and reliability
Case Study – New PW plant
Project Verification Plan
Roles and responsibilities.
Project Verification Plan.
Procesos / Grupos implicados Tipo de
Entregables doc.
R = Respons. for assuring it's done I = Informed P= Proyecto
A = Approver E= Execute or performs
C = Consulted (SME) L= Ciclo de
vida
Verificación Operaciones
System
Ingeniería / Servicios Automation QA EHS
Owner
Técnicos
Design Basis (BODs) A R/A/E C A/E C C P

Business / Operation /
C R/A/E C C C C/A P
Safety Risk Assessment
Requirements Document
C R/A/E I C A I L
(RD)
Quality Risk Assessment
C R/A/E I C A I L
(QRA)
Verification Quality
Strategy C R/A/E I C A I P
(VQS)
Vendor Assessment (VA) I R/A/E I A/E A I P
Design Specs /
Functional Specs (DS / C R/A/E I R/A/E C I L
FS)
Project Verification Plan
A R/A/E C A/E A C P
(PVP)
Design Review Process C R/E I E C C P
Design Review Summary
A R/A/E I A A C L
Report (DRSR)
Verification Testing (VT) C R/A/E C A/E C I P
System Acceptance &
A R/A/E I A A I L
Release Report (SARR)
Requirement Document
Requirement Document
Design Review
Design Review summary Report
Verification Quality Strategy
Verification Testing
System Acceptance and Release
Report
Lessons Learned
Questions?
Carmen María Capón

[email protected]
+34 91 334 65 97
Wyeth Farma S.A.

Autovía del Norte A-1
Km. 23 Desvío Algete Km. 1
28700 San Sebastián de los Reyes, Madrid
SPAIN
•Backup slides
Areas of Opportunity within Verification
#1 Flexibility and Scalability
• Flexible / scaleable approach and documentation – based on risk to
patient safety/product quality
#2 Leverage GEP & Subject Matter Experts

• Earlier establishment and support of Tech Services and Engineering to
identify equipment and component design requirements to support
Critical Aspect development. Greater confidence in GEP allows
reduction of Quality oversight.
#3 Leverage Supplier Documentation

• Assessment of vendors for compliance to Verification requirements
allows Vendor testing & documentation to be used with confidence
#4 Avoid repetition of tests
• Single test activity
• Critical Aspect testing based on Verification Quality Strategy
• GEP testing of all critical and non-critical items
• Integrated testing of equipment/process control
• Leverage testing conducted throughout the system implementation life
cycle
• For critical aspects have QA pre-approved acceptance criteria
• May leverage vendor testing results (acceptance criteria agreed during
Requirements Document approval)
#5 Reduce Periodic Review Scope – Focus on Criticality to
Products/Processes identifies ”systems” that are truly critical e.g.,
• Project Lifecycle compliance
• Asset Management compliance
• Site Change Control compliance
• Quality Assurance System compliance
#6 Reduce number of documents generated, reviewed, approved

& retained
• Integrated equipment & automation test documents and reports
• Revision control of automation Detailed Design Specification
documents (30% - 40% less pages in the test documents)
#7 Targeted Critical Aspects of Manufacturing Systems
• Asset management (Calibration and PM)

• commensurate to risk ranking and asset classification
• Reduction in overall number of site Critical components and
instrumentation
In summary –
• Applies Science & Risk based approaches to enhance the focus on

Critical Aspects of the manufacturing system that affect product
quality/patient safety
• Critical Aspects for Manufacturing Systems are based on
product/process requirement(Critical Quality Attributes (CQA), Critical
Process Parameters (CPPs) and regulatory/PQS requirements)
• Use of Quality Risk Management (QRM) principles to evaluate risks to
product quality/patient safety

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Aplicación de la

Verification •Testing is a single GEP

•Single close out report for

Design Basis (BODs) A R/A/E C A/E C C P

Carmen María Capón

Wyeth Farma S.A.

#2 Leverage GEP & Subject Matter Experts

#3 Leverage Supplier Documentation

#6 Reduce number of documents generated, reviewed, approved

• Asset management (Calibration and PM)

• Applies Science & Risk based approaches to enhance the focus on

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