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E-raamat: Validating Pharmaceutical Systems: Good Computer Practice in Life Science Manufacturing

Edited by (KMi, Denham, UK)
  • Formaat: PDF+DRM
  • Ilmumisaeg: 03-Aug-2005
  • Kirjastus: CRC Press Inc
  • Keel: eng
  • ISBN-13: 9780203500439
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Validating Pharmaceutical Systems: Good Computer Practice in Life Science ManufacturingSuurem pilt
  • Formaat: PDF+DRM
  • Ilmumisaeg: 03-Aug-2005
  • Kirjastus: CRC Press Inc
  • Keel: eng
  • ISBN-13: 9780203500439
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All too often, the words "computer validation" strike terror into the hearts of those new to the process and may even cause those familiar with it to tremble. Validating Pharmaceutical Systems: Good Computer Practice in Life Science Manufacturing delineates GCP, GLP, and GMP regulatory requirements and provides guidance from seasoned practitioners on how to fulfill them. John Andrews and his team tackle the perceived complexities surrounding the validation of a wide variety of automated systems.

Sprinkled with case studies and real-life examples, the book offers a step-by-step review of topics such as planning, design, auditing, risk management, and specification. The in-depth, by example coverage demystifies the challenges of manufacturing execution systems(MES), laboratory information management systems(LIMS), and network qualification.

The first section examines the different levels of automated systems used throughout the drug development, manufacture, and delivery lifecycle, using the GAMP 4 lifecycle approach to their validation. The second section uncovers some real-life applications of GAMP 4 to different areas of the regulations such as GLP, GCP, GMP, and GDP.

The book explores some of the latest thinking on computer validation and reflects changes that have occurred in the industry since the early days of validation. The contributors are a deliberate blend of those who have faced the problems of the 1990s and the Y2K controversies and those who have more recently arrived on the scene and made an impact on the perception of validation of automated systems across the field of GxP. They do more than show you how to do the right thing; they show you how to do the right thing in compliance with regulations.
The Editor and His Contributors vii
Foreword xv
Guy Wingate
Editor's Introduction xix
John Andrews
Chapter 1 Considerations for Computerized System Validation in the 21st Century Life Sciences Sector 1(68)
Tony de Claire, Peter Coady, and Nicola Stevens
Introduction
3(3)
Life Cycle Processes
6(5)
Computerized Systems Validation
11(16)
Validation SOPs
13(1)
System and Application Evaluation
14(1)
System Register
15(1)
Validation Plan
15(3)
Qualification Protocols
18(6)
Design Qualification
18(2)
Installation Qualification
20(1)
Operational Qualification
21(1)
Performance Qualification
21(3)
Validation Report
24(1)
Periodic Review
25(2)
Computerized Systems Development
27(12)
User Requirements Specification (URS)
27(1)
Supplier Audit
28(1)
Supplier Quality Management System
29(2)
Requirements Traceability
31(1)
System Development Life Cycle
32(1)
System Description
33(1)
Development Methodologies
34(1)
System Development Testing
35(2)
Data Migration
37(1)
System Documentation
38(1)
Computerized Systems Operation
39(5)
System Location
39(1)
System Changes
40(1)
Error and Problem Reporting
40(1)
Backup and Archiving
41(1)
Disaster Recovery and Business Contingency Planning
42(1)
System Maintenance and Support
42(1)
System Decommissioning and Retirement
43(1)
Inspection Readiness
43(1)
Electronic Records and Electronic Signatures
44(14)
FDA Guidance for Industry, Part 11, ERES - Scope and Application
44(5)
Predicate Rules and Part 11
45(1)
Narrow Interpretation of Scope
45(1)
What the FDA Still Intends to Enforce When Part 11 Applies
45(1)
The Life Sciences Industry's Responsibilities
46(1)
Validation
47(1)
Hybrid Systems (Paper and Electronic Records)
47(1)
Electronic Signatures
47(1)
Audit Trails
47(1)
Copies of Records
48(1)
Retention of Records
48(1)
Legacy Systems
48(1)
Electronic Records Compliance
49(5)
Validation Requirements
49(1)
System Access
50(1)
Data Entry Checks
50(1)
Audit Trails
51(1)
Copies of Data
51(1)
Data Security
52(1)
Batch Release and Qualified Persons
52(1)
Documentation Control
53(1)
Open Systems
54(1)
Electronic Signatures Compliance
54(4)
Association with Electronic Records
54(1)
Accountability
55(1)
Meaning and Timestamps
55(1)
Security - Personnel
56(1)
Security - Equipment
57(1)
Security - Continuous and Interrupted Access
57(1)
Personnel
58(3)
Roles and Responsibilities
59(2)
Summary
61(1)
Definitions
62(1)
References
63(6)
Chapter 2 An Inspector's Viewpoint 69(16)
Sam Clark
Introduction
69(2)
Design
71(6)
Validation
77(2)
Change Control
79(2)
Closing Remarks
81(1)
References
82(3)
Chapter 3 State-of-the-Art Risk Assessment and Management 85(28)
John Andrews
Introduction
86(1)
Risk Assessment Techniques
87(12)
Failure Mode Effect Analysis (FMEA)
87(3)
Introduction
87(1)
Method
87(2)
Strengths
89(1)
Weaknesses
89(1)
Failure Mode Effect Cause Analysis (FMECA)
90(1)
Introduction
90(1)
Strengths and Weaknesses
90(1)
Hazard Analysis Critical Control Points (HACCP)
90(5)
Introduction
90(1)
Method
91(4)
Strengths
95(1)
Weaknesses
95(1)
Fault Tree Analysis (FTA)
95(3)
Introduction
95(3)
Strengths
98(1)
Weaknesses
98(1)
The GAMP Model
98(1)
Application to the Validation of Computerized Systems
99(2)
Risk Management
101(4)
High Level GxP Determination
101(4)
System Impact Assessment
101(1)
Subsystem Impact Assessment
102(1)
Functional Risk Assessment
102(3)
Application to Part 11
105(4)
Step 1 Does the System Impact Part 11?
105(1)
Step 2 Risk Management
106(2)
Step 3 Part 11 Assessment
108(1)
Process Analytical Technology (PAT)
109(1)
Conclusion
110(1)
Further Reading
110(1)
References
110(3)
Chapter 4 Validation Planning and Reporting 113(54)
Chris Clark
Introduction
114(1)
Validation Planning
115(4)
Overview of Planning in the Validation Life Cycle
115(2)
Purpose of the Validation Plan
117(1)
Relationships with Other Life Cycle Phases and Documents
118(1)
Key Planning Activities
119(15)
Formation of Project Team
119(2)
Analyze the GMP Implications
121(3)
Develop Validation Approach and Strategy
124(6)
Write the Validation Plan
130(2)
Review the Validation Plan
132(1)
Approve the Validation Plan
133(1)
Document Management and Control
134(1)
Format and Content of the Validation Plan
134(9)
Introduction and Project Overview
135(1)
System Description
136(2)
Validation Approach
138(1)
Validation Documentation
139(1)
Validation Documentation Procedures
140(1)
Training Requirements
141(1)
Validation Organization
141(1)
Validation Activity Schedule and Timeline
142(1)
Maintenance of Validation Status
142(1)
Appendices
143(1)
Checklist for Completion of a Validation Plan
143(3)
Validation Reporting
146(4)
Overview of Validation Life Cycle
146(1)
Purpose of the Validation Report
146(3)
Relationships with Other Life Cycle Phases and Documents
149(1)
Key Reporting Activities
150(5)
Review Phase Requirements
150(2)
Collate and Analyze the Results Obtained
152(1)
Collate and Analyze the Issues Raised
152(1)
Write the Validation Report
153(1)
Review the Validation Report
153(1)
Approve the Validation Report
154(1)
Document Management and Control
155(1)
Format and Content of a Validation Report
155(9)
Introduction
156(1)
Summary of Phase Results
157(1)
Phase Execution
158(3)
Prerequisites
158(2)
Project Environment
160(1)
Exclusions
160(1)
Details of Phase Execution
160(1)
Comprehensive Results Breakdown
161(1)
Problem Reporting and Resolution
161(2)
Validation Status
163(1)
Glossary
164(1)
Appendices
164(1)
Checklist for Completion of a Validation Report
164(2)
Glossary
166(1)
References
167(1)
Chapter 5 Supplier Audits: Question and Answers 167(28)
Guy Wingate
Introduction: Twenty Frequently Asked Questions
168(1)
Q1 What Is Computer Validation?
168(1)
Q2 How and by Whom Are Computer Systems Validation Activities Regulated?
169(1)
Q3 Who Is Responsible for Validating Computer Systems?
169(1)
Q4 Why Do Customers Conduct Audits?
170(1)
Q5 Is There a Standard Audit Process?
170(1)
Q6 When Is an Audit Required?
171(1)
Q7 What Is the Scope of an Audit?
171(4)
Q8 What about Electronic Records and Electronic Signatures?
175(1)
Q9 Who Conducts the Audit?
176(1)
Q10 How Will the Audit Be Conducted?
176(1)
Q11 When and How Will Suppliers Be Contacted in Regard to an Audit?
177(1)
Q12 What Happens in a Quality Review?
178(1)
Q13 What Happens in a Postal Audit?
178(1)
Q14 What Happens in a Full Supplier Audit?
179(1)
Q15 What Happens after an Audit?
180(1)
Q16 Are Audit Reports Confidential?
181(1)
Q17 Can a Regulator Such as FDA or MHRA Inspect a Supplier?
181(1)
Q18 Can Suppliers Be Approved by Regulators?
182(1)
Q19 What Is an Escrow Account?
182(1)
Q20 Where Can I Get More Guidance and Advice?
183(1)
Summary
183(1)
Abbreviations
183(1)
Terminology in Brief
184(1)
References
184(1)
Appendix A ISO 9000 Clauses
184(1)
Appendix B Supplier Audit Postal Questionnaire
185(3)
Appendix C Full Supplier Audit Checklist
188(4)
Appendix D Checklist for Customer Audits
192(3)
Chapter 6 Developing Good Specifications 195(14)
Mark Cherry
General Considerations
196(2)
GxP Considerations
198(1)
User Requirement Specification Sections
199(5)
Introduction
200(1)
System Overview
200(1)
System Interfaces
200(1)
Functional Requirements
201(2)
Data Requirements
203(1)
System Requirements
204(1)
System Security
204(1)
Electronic Record (ER) Controls
204(1)
Electronic Signature Requirements
205(1)
Environmental Factors
205(1)
Operating Procedures and Training Requirements
206(1)
Health and Safety
206(1)
Process Equipment
206(1)
System Interfaces
207(1)
System Maintenance and Availability
207(1)
Project Requirements
207(1)
Quality System Requirements
208(1)
Revision History
208(1)
Appendices and References
208(1)
Chapter 7 Traceability of Requirements Throughout the Life Cycle 209(16)
Keith Collyer and Jeremy Dick
Introduction
210(1)
Systems Engineering and Requirements Management
210(2)
Introduction
210(1)
Projects Are Tough
210(1)
Requirements Are Vital
211(1)
Traceability
212(5)
Information Models
212(3)
Rich Traceability
215(2)
The Role of Models
217(1)
Generic or Specific?
218(4)
Overview
218(3)
Agreement
221(1)
Analysis
221(1)
Derivation
221(1)
Qualification
222(1)
Build
222(1)
Risks, Issues, and Assumptions
222(1)
Overview
222(1)
Risks
222(1)
Issues and Assumptions
223(1)
Summary and Conclusions
223(1)
References
223(2)
Chapter 8 Good Documentation in Practice 225(16)
Michael L. Wyrick
Introduction
226(2)
Purpose
227(1)
Scope
227(1)
Rationale
227(1)
Document Management Tasks
228(1)
Document Standards
228(7)
Assumptions
228(1)
Content
228(3)
Title
229(1)
Document Approval
229(1)
Revision History
230(1)
Table of Contents
230(1)
Definitions and Acronyms
231(1)
References
231(1)
Document Information and Attributes
231(1)
Other Document Formats
231(1)
Document Appendices
231(2)
Document and Record Management
233(2)
Creating and Modifying Documents
233(1)
Signature Routing
233(1)
Checking in Documents
234(1)
Master Document List (MDL)
234(1)
Document Retention
235(1)
Revising Documents
235(1)
Distribution
235(1)
Handwritten Record Entries
235(2)
Assumptions
235(1)
Signatures and Entries
235(1)
Corrections
236(1)
Changes or Additions to Records
236(1)
Signature and Initial Logs
236(1)
Security and Access
237(1)
Electronic Document Security
237(1)
Hard Copy Document Security
237(1)
Glossary and References
237(5)
Definitions and Acronyms
237(2)
Reference Documents
239(2)
Chapter 9 Good Testing Practice: Part 1 241(22)
David Stokes
Introduction
242(1)
Definitions
243(1)
General Testing Terms
243(1)
Testing, Verification, and Validation
243(1)
Why Test?
244(2)
"On the Road Again..."
244(1)
Testing in Life Sciences
245(1)
Testing Within the Validation Life Cycle
246(2)
Start "Testing" Early
246(1)
Specifications and Requirements
247(1)
Test Strategy
248(8)
The Test Strategy
248(1)
Testing and Risk Assessment
248(3)
The Nature and Scope of Testing
251(5)
The Nature of Testing
251(1)
Testing Scope
251(4)
How Much Testing Is Enough?
255(1)
The Test Plan
256(3)
Test Objectives
257(2)
Test Coverage and Traceability
259(1)
Test Procedures and Training
259(1)
In Summary
260(1)
References
261(2)
Chapter 10 Enterprise Resource Planning Systems - Aligning Business and Validation Requirements 263(28)
A. Nobibux, Julien Peters, Steve Sharp, and James Stafford
Key Differences in ERP System Usage within Regulated Organizations
265(2)
Optimizing the Methodology
267(6)
Implementer's Methodology May Be Incomplete
267(2)
Organizations' Computer Validation Methodology Inappropriate
269(2)
Company's IS Organization and Processes Inappropriate
271(1)
Quality Planning Component of Project Methodology Required
271(2)
Initial Engagement
273(2)
Understanding the Project Context
274(1)
Cost-Effective Delivery
274(1)
Appropriately Incentivized Implementers
275(1)
Vendor and Implementer Selection
275(1)
Project Initiation
275(2)
Integration of Implementation and Validation Work Streams
276(1)
Validation Awareness
277(1)
Solution Design
277(4)
User Requirements Specification
278(3)
Evolution of Solution Design
281(1)
Functional Requirements Specification
281(1)
Technical Requirements
281(1)
Solution Build
281(1)
Design Qualification
282(1)
Test Scripting and User Operating Procedures
282(1)
Data Migration
282(1)
Solution Migration
282(3)
Test Planning and Execution
283(1)
Test Procedure and Types
283(1)
Operational Readiness
284(1)
Qualification Reports
285(1)
Go Live
285(1)
Go Live Is a Process Not Solely a Decision
285(1)
Vindication of Go-Live Decision
286(1)
Operational Support
286(3)
Consolidation and Improvement
286(1)
Operations Governance
287(1)
Support Model
288(1)
Quality Management
289(1)
References
289(2)
Chapter 11 Calibration in Practice 291(32)
Mark Foss
Introduction
292(1)
Why Calibration Is Important to Validation?
292(1)
Key Regulatory Requirements
293(1)
Prioritization
294(1)
Criticality Assessment
295(3)
Calibration Interval
296(1)
Adjustment of Calibration Interval
297(1)
Calibration
298(1)
Uncertainty
298(2)
Equipment Selection
300(15)
Instrument Selection and Types
300(2)
Construction
302(5)
Suppliers
307(1)
Handling
308(1)
Installation
308(2)
Smart Instrumentation
310(1)
Automation
311(1)
Smart Calibrators and Test Equipment
312(1)
Third Party Calibration
313(1)
Instrument Qualification
314(1)
Conclusions
314(1)
Instrument Validation
315(1)
Documentation
316(4)
Exception Report
317(1)
Calibration Results Sheets
317(2)
Change Control
319(1)
Auditing
320(1)
Training
320(1)
Summary
321(1)
Glossary
321(1)
References
322(1)
Chapter 12 Validating Legacy Systems 323(48)
Siegfried Schmitt
Overview
324(1)
Introduction
324(3)
The Assessment Process
327(21)
The Strategy Document
328(2)
The System Assessment Documents
330(15)
The System Inventory
331(2)
GAMP Categorization
333(3)
General and Detailed Assessment Protocols
336(1)
The General Assessment Protocol
336(5)
The Detailed Assessment Protocol
341(2)
Training
343(2)
The Assessment
345(2)
Results and Options
347(1)
Managing Legacy Systems (Execution)
348(18)
Decommissioning (System Retirement)
349(1)
Redefining the System
350(1)
Replacement or Upgrade?
350(1)
Hybrid Systems and Procedural Controls
351(2)
Practical Examples
353(12)
Validation
365(1)
Ongoing Operations
366(1)
Summary
366(2)
References
368(1)
Suggestions for Further Reading and Related Websites
369(2)
Chapter 13 Technology Transfer Keys 371(28)
Stewart Green and Paul Warren
Introduction
372(1)
The Technology Transfer Team
372(2)
Technology Transfer: Key Activities
374(19)
Timelines
374(1)
Regulatory Issues
375(5)
Determining the Process Scope
380(1)
Managing Change
380(1)
Documentation
381(1)
Validation
382(9)
Process Validation
383(4)
Cleaning Validation
387(11)
Analytical Validation
398
Protocol
390(1)
Packaging Issues
391(1)
Stability Requirements
392(1)
Training
393(1)
The Technology Transfer Report
393(2)
Contents
393(2)
Approval Process
395(1)
Post-Transfer Evaluation
395(1)
Technology Transfer Checklist
396(1)
Sources of Information
396(3)
Chapter 14 Qualifying SCADA Systems in Practice Acquisition 399(22)
Orlando Lopez
Background
399(1)
Introduction
400(1)
SCADA Systems
401(2)
Part 11
403(1)
Part 11 and SCADA
404(1)
Qualification and Project Life Cycle
405(2)
Business and Regulatory Requirements
407(12)
Software Configuration and Hardware Specifications
408(4)
Configuration and Installation
412(2)
Qualification Testing
414(2)
System Use and Performance Evaluation
416(3)
References
419(2)
Chapter 15 The Application of GAMP 4 Guidelines to Computer Systems Found in GLP Regulated Areas 421(14)
Paul Coombes
Part 1 The Academic Side of the Subject
421(6)
Part 2 The Practical Side of the Subject
427(5)
Definitions of the Main Acronyms in This
Chapter
432(2)
References
434(1)
Chapter 16 The Validation of a LIMS System - A Case Study 435(26)
David Hogg and Fernando Pedeconi
Overview
436(1)
LIMS in the Pharmaceutical Industry - Introduction
436(1)
LIMS Software Development Life Cycle and Validation
437(11)
The Validation Roadmap - Requirements for a New or Existing System
439(1)
Risk Management and Traceability Matrix
440(1)
21 CFR Part 11 - Considerations within a LIMS Environment
441(2)
Building or Customizing the System - Giving Shape to the Application
443(2)
The System Database
443(1)
Interfacing with Other Business Systems
444(1)
The User Interface
445(1)
Pre-"Cut Over" Testing and "Go or No Go" Decision
445(2)
Post "Cut Over" Testing Performance Qualification
447(1)
Special Considerations
448(2)
Data Archiving and Migration
448(1)
Reporting and Query Tools
448(1)
Disaster Recovery and Business Continuity
449(1)
Maintenance
450(1)
Case Study: A LIMS in AstraZeneca
450(9)
Background and Resource Issues
451(1)
Generation of Proposals
451(1)
Assessment of Proposals
452(1)
Project Planning and Start-Up
453(1)
Documentation Development and Management
454(2)
Validation Plan
454(1)
Functional Specification
454(1)
Hardware Design Specification
454(1)
Software Design Specification
454(1)
Protocol
455(1)
Validation Report
456(1)
Procedures
456(1)
Project Monitoring
456(1)
Risk Assessment
457(1)
Conclusions
458(1)
References
459(2)
Chapter 17 Compliance and Validation in Central and Eastern Europe (CEE) 461(12)
Paul Irving, Carl Turner, Wayne Duncan, and David Forrest
Introduction
461(1)
The European Marketplace
462(2)
Healthcare Spending in Western Europe
463(1)
Healthcare and IT Spending in Eastern Europe
463(1)
Key Areas of GAMP for Emerging European Countries
464(7)
IT and Automated Systems
464(3)
Communication, Training, and Education
467(1)
IT Infrastructure
467(1)
Validation Planning
468(1)
Supplier Audit
469(1)
Risk Management
470(1)
Software Engineering Techniques
470(1)
Conclusions
471(2)
Chapter 18 Distribution Management Validation in Practice 473(18)
Ben Gilkes
The Scenario
473(2)
Developing the Protocol
475(10)
Maintaining the Validated State
485(1)
Legacy System Review
485(2)
Electronic Records and Signatures
486(1)
Specific Validation Work
487(1)
The Regulatory Environment
488(1)
Moving Forward
489(1)
Tackling and Solving Problems
489(1)
References
490(1)
Chapter 19 Good Testing Practice: Part 2 491(16)
David Stokes
Introduction
492(1)
More Speed, Less Haste
492(1)
Key Roles
492(1)
Scalability
493(1)
Managing the Paperwork
493(1)
Automated Test Tools
494(1)
Focus on the Processes
495(2)
Fundamental Understanding
497(6)
"Test Everything"
498(1)
"Ensure Complete Traceability"
498(1)
"Sign Every Step"
499(1)
"Everything Should Be Witnessed"
500(1)
"Record Everything"
501(1)
"Use Only Black Ink"
501(1)
"Review Everything"
502(1)
Testing
503(3)
The Test Team
504(1)
Test Execution
504(1)
Test Review and Incident Analysis
505(1)
Test Metrics and Statistics
505(1)
Summary
506(1)
Chapter 20 Practical Applications of GAMP Version 4 507(18)
Siegfried Schmitt
Introduction
507(1)
Vendor Auditing Using GAMP4 Guidance and Templates
508(12)
A Company Overview
509(1)
B Organization and Quality Management
510(2)
C Planning and Product, Project Management
512(1)
D Specifications
512(1)
E Implementation
513(1)
F Testing
514(2)
G Completion and Release
516(1)
H Support and Maintenance
517(2)
I Supporting Procedures and Activities
519(1)
Training in GAMP 4
520(2)
Who Are You Talking To?
522(1)
References
523(2)
Chapter 21 Glossary and Abbreviations 525(12)
Orlando Lopez
Index 537


John Andrews
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