Good Computer Validation Practices

Transcription

1 Good Computer Validation Practices Common Sense Implementation Teri Stokes Ronald C. Branning Kenneth G. Chapman Heinrich J. Hambloch Anthony J. Trill Interpharm Press, Inc. Buffalo Grove, IL

2 Contents Preface xi 1 Computer Validation Projects, Problems, and and Solutions: An Introduction 1 Anthony J. Trill Large Projects Controversy and Disasters 1 Pharmaceuticals and Devices Quality and Safety Issues - 2 Computerized Systems People and Procedures 3 Building Quality into Systems (SDLC and GSEP) 4 EC GMP Requirements and Personal Responsibilities 5 EC Rules and Guidance for Pharmaceutical Manufacturers 6 Information Management Strategies 9 Conclusions 9 References 10 HI

3 iv Contents 2 International Regulations and Computer Systems: GCP/GLP/GMP 11 Dr. Ten Stokes GLP Computer Systems UK, Japan, United States 12 Common Themes GLP Computer Systems 16 GCP Computer Systems Scandinavia, Australia, EC, United States 16 Common Themes GCP Computer Systems 24 GMP Computer Systems Pilot and Production- Specific Guidelines 24 Conclusion 31 References 31 3 The Role of Senior Management in Computer Systems Validation 35 Dr. Ten Stokes What Is the Validation Role of Senior Management? 36 What Should a Validation Policy Document Contain? 38 How Does One Implement Corporate Validation Policy? 42 How Do We Get from Corporate Policy to a Validated System? 45 Conclusion 45 Reference 46 4 Documentation Practices and Principles 47 Kenneth G. Chapman Validation Document Categories 48 Document Quality 50

4 Contents v Starting Principles 57 Actual Documents 59 What's Missing? 71 References 71 5 Validation Concepts and Key Terminology 75 Kenneth G. Chapman Some Key Terms 76 Summary 89 References 89 6 Existing Computer Systems: A Practical Approach to Retrospective Evaluation 93 Dr. Heinrich Hambloch A Strategy for Retrospective Evaluation 94 The Phases of Retrospective Evaluation 95 A Practical Example 101 Conclusion 102 References Data Center Management and Good Practices 113 Heinrich Hambloch The Principle of SOPs and Forms in the Pharmaceutical Industry 115 Application of SOPs and Forms to Computer Systems 115 A Typical Departmental Computer Center 116

5 vi Contents SOPs for the Operation of a Department Computer Center 117 Summary 133 Reference Audit of External Software Vendors 141 Dr. Heinrich Hambloch The Planning of the Audit 142 The Realization of the Audit 144 Evaluation of the Audit. 154 Summary 155 References Clinical Data Systems, GCP Validation, and CANDA 157 Dr. Ten Stokes Business Life Cycle for GCP Validation 158 The GCP Difference for Computers 161 Data Systems That Are GCP Regulated 161 Where Companies Usually Start GCP Systems Validation 162 Membership of the GCP Validation Team 163 The Role of the GCP Validation Team & the Test Plan Working Group 164 Software Validation Plan for an Existing CRF Management System 167 GCP Validation and CANDA Support 172

6 Contents vii Conclusion 176 References Computerized Laboratory Systems and GLP 179 Dr. Ten Stokes Point 1 Inventory All Types of Computer Use in the Laboratory 180 Point 2 Assess GLP Relevance for Specific Hardware and Software Used 181 Point 3 Establish a General Laboratory QA Policy for IT Compliance to GLP Standards 181 Point 4 Audit the Development of In-House and Vendor-Supplied Systems 182 Point 5 Create a Collaborative Philosophy for QA Computer Audits 186 Point 6 Monitor Ongoing Operation and Maintenance of Regulated Systems 187 Point 7 Prepare a Standard Procedure for Audits and Inspections 191 Point 8 Document All Compliance Activities 192 Summary 194 References Computerized Systems Validation: Preparation 197 for an FDA Bioprocess Inspection Ronald C. Branning SOP for Computerized System Validation 199 Computerized System Validation Protocol 200 Definitions 202

7 viii Contents Regulatory Environment 203 Initial Consideration for System Computerization 204 Specifying Computer Systems 206 PMA Life Cycle Approach 206 Computer Control of Bioreactor Processing 213 Conclusion 217 References Organization and Training for Validation 221 Ronald C. Branning Regulatory Requirements 221 Validation Master Plan (VMP) A Regulatory Perspective 231 Anthony J. Trill The Potential Benefits of New Technology 231 Computer Systems Assessment Inspector Concerns 234 EC GMP Requirements 238 Paperless Systems 243 Quality Assurance of Software and Systems Projects 244 Software Certification 251 Validation of Existing Systems 252 Critical Applications 256 Packaging Line Applications 258 Database Packages and Integrated Systems 259 Evidence of Structured Quality Systems 260

8 Contents ix Preparing for an Inspection Conclusions Acknowledgements References Appendices A Acronyms 275 B Glossary 279 C Drumbeat Analysis 287 D European Commission GMP Annex 11 Analysis 295 E Australian Code of GMP Analysis 301 F Recommended Reading 307 Index 313