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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 .

Verification general concepts .

Verification general concepts .

Changing Roles & Responsibilities •Requirements •Focused on Product/Process and Regulatory/PQS Requirements only •Engineering Document for User and other requirements (I. EH&S) •Verification Quality Strategy: Top down approach based on Requirements Document and design review •Testing Verification Testing •Testing is a single GEP activity – covering commissioning. SAT & IOQ •Close-out Report(s) IOQ Task Reports •Single close out report for system . FAT.e.

Changing Roles & Responsibilities .

#7 Targeted Critical Aspects of: * Manufacturing Systems (reduce site Critical components) * Engineering Operations * Cost improvements Verification .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.

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 .

Project Verification Plan. P= Proyecto L= Ciclo de vida Verificación System Owner Design Basis (BODs) Business / Operation / Safety Risk Assessment Requirements Document (RD) Quality Risk Assessment (QRA) Verification Quality Strategy (VQS) Vendor Assessment (VA) Design Specs / Functional Specs (DS / FS) Project Verification Plan (PVP) Design Review Process Design Review Summary Report (DRSR) Verification Testing (VT) System Acceptance & Release Report (SARR) Ingeniería Operaciones / Servicios Automation Técnicos QA EHS A C C C C I C A C A C A R/A/E R/A/E R/A/E R/A/E R/A/E R/A/E R/A/E R/A/E R/E R/A/E R/A/E R/A/E C C I I I I I C I I C I A/E C C C C A/E R/A/E A/E E A A/E A C C A A A A C A C A C A C C/A I I I I I C C C I I P P L L P P L P P L P L . Procesos / Entregables Grupos implicados R = Respons.Roles and responsibilities. for assuring it's done A = Approver C = Consulted (SME) I = Informed E= Execute or performs Tipo de doc.

Requirement Document .

Requirement Document .

Design Review .

Design Review summary Report .

Verification Quality Strategy .

Verification Quality Strategy .

Verification Quality Strategy .

Verification Testing .

System Acceptance and Release Report .

Lessons Learned .

A. 23 Desvío Algete Km. 1 28700 San Sebastián de los Reyes. Madrid SPAIN . Autovía del Norte A-1 Km.com +34 91 334 65 97 Wyeth Farma S.Questions? Carmen María Capón carmen.caponborrego@pfizer.

•Backup slides .

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 .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.

Areas of Opportunity within Verification #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) .

• • • • Project Lifecycle compliance Asset Management compliance Site Change Control compliance Quality Assurance System compliance #6 Reduce number of documents generated..40% less pages in the test documents) . approved & retained • Integrated equipment & automation test documents and reports • Revision control of automation Detailed Design Specification documents (30% .Areas of Opportunity within Verification #5 Reduce Periodic Review Scope – Focus on Criticality to Products/Processes identifies ”systems” that are truly critical e.g. reviewed.

Critical Process Parameters (CPPs) and regulatory/PQS requirements) • Use of Quality Risk Management (QRM) principles to evaluate risks to product quality/patient safety .Areas of Opportunity within Verification #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).