Training Course Computerized System Validation in the Pharmaceutical Industry Istanbul, 16-17 January 2003 Industry Guidelines Industry Guidelines for Computerized Systems Validation for Computerized Systems Validation (GAMP, PDA Technical Reports) (GAMP, PDA Technical Reports) Wolfgang Wolfgang Schumacher Schumacher Roche Roche Pharmaceuticals, Pharmaceuticals, Basel Basel
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Training CourseComputerized System Validation in the Pharmaceutical IndustryIstanbul, 16-17 January 2003
Industry Guidelines Industry Guidelines for Computerized Systems Validationfor Computerized Systems Validation
GAMP 4 GAMP 4 -- Project Management and ControlProject Management and Control
Validation PlanningQuality and Project Planning Document MangementRisk ManagementDesign Review
- including Traceability AnalysisProject Change ControlConfiguration ManagementValidation Reporting
GAMP 4 GAMP 4 -- Good Practice Definitions (Good Practice Definitions (11.1 to 11.3)11.1 to 11.3)
Revised good practices
Good documentation practice
Good testing practice
Good engineering practice
GAMP 4 GAMP 4 -- Operational Support GuidelinesOperational Support Guidelines
Backup and Recovery Business Continuity PlanningOperational Change Control Performance Monitoring Periodic ReviewRecord Retention, Archive and RetrievalSecurity Service Level Agreements
GAMP Good Practice GuidanceGAMP Good Practice Guidance(Topics Under Consideration)(Topics Under Consideration)
Legacy SystemsInfrastructureProcess Systems“Skid Mounted” EquipmentCalibration*Electronic Records and Signatures*Analytical Laboratory EquipmentGlobal IT SystemsGood Engineering PracticeWeb-based Applications * Published
IT Infrastructure IT Infrastructure -- Important AspectsImportant Aspects
design specification
layout and hierarchical drawings
installation records
change control
Front-end
Back-end
Applications
Network
2 GxP-relevant business applicationsdealing with GxP-data
3 GxP-relevant infrastructure thatdelivers a qualified platform
Network (WAN/LAN)
Back-end (servers)
Front-end (desktops)
Platforms and middleware*
Key processes
* also called enablers, core or base applications
Business
1 2
Key
Platforms
Middleware
Processes
1
2
The IT Infrastructure elements
IT Infrastructure IT Infrastructure -- the Qualificationthe Qualification LifecycleLifecycle
TechnicalDesign-
Specification
FunctionalSpecification
Requirementor Service
Specification
IQ Form
OQ FormIQ Report
OQ Report
2. Specification
3. Define test& acceptance
criteria4. Testing
5. Review& Report
1. Planning
create
create
createexecute
compile
QualificationCertificate
QualificationReportQualificationReport
QualificationReportQualificationPlan
Change Control
The APV interpretation of The APV interpretation of Annex 11 EU Guide to GMPAnnex 11 EU Guide to GMP
Published already in 1994Regulators contributed to interpretationGood document, easy to readContains many useful information English translation in GAMP 4
PDA Technical Report No. 18PDA Technical Report No. 18Validation of Computer Related SystemsValidation of Computer Related Systems
Published in 1994Consultants contributed to guidanceContains advanced, but useful informationRecommended reading for CSV beginnersCan be ordered via PDA
PDA: Parenteral Drug Association
PDA PDA Technical Report No. 31Technical Report No. 31Validation and Qualification of Laboratory Data Acquisition Systems (LDAS)
Published in 1999Contains advanced information for LDAS system ownersRecommended reading for LDAS expertsCan be ordered via PDA
PDA: Parenteral Drug Association
PDA PDA Technical Report No. 32Technical Report No. 32Auditing of Suppliers providing computer products for regulated pharmaceutical operations
Published in 1999Contains advanced information for auditors of computerized system suppliersRecommended reading for AuditorsCan be ordered via PDA