Setting up a GXP environment where none existed previously is a very daunting task. Getting staff to write down what they do for every task is a correspondingly difficult and time-consuming exercise. Examining how to maintain quality control in clinical trial research, A Practical Guide to Quality Management in Clinical Trial Research provides a cornerstone of knowledge for establishing a quality system that complies with the relevant regulations. There are many books available that cover how to interpret regulations. Going a step or two further, this book provides practical advice that is useful on a daily basis.
The book contains information for various standards including GLPs, GCPs, and GMPs. It gives detailed explanations of how to prepare, update, and maintain SOPs and includes advice on training and development of personnel. Drawing directly on his years of experience, the author delineates a from-the-trenches methodology that creates a value-added quality management system from a business perspective. He provides a solid foundation as well as tips and techniques for establishing a quality system that will comply with all the relevant regulations. The author's integrated approach and anecdotal style turns technically accurate information into easy reading. The book arms you with tools and concepts that you can use to go beyond regulatory compliance and move into the realm of business quality improvement.
Table of Contents
IN THE BEGINNING THERE WAS GLP
Staff Perception of QA
Qualities of a Quality Professional
Training the Quality Professional
A Workable Quality System (Pseudo-GLP)
Application of GLP Principles to Phase-I Clinical Trials
SOP and Design
Laboratory Method Operating Procedures (MOPs)
Preambles for SOPs
Achieving the Purpose of SOP
Building a Quality Assurance System
Quality Control within Quality Assurance
Staffing Issues: Meeting the Needs
Quality System Evolution
Ethical Permission to Carry Out a Study
Clinical Protocol Audits
Control of Test Substances
Problems with Nomenclature and Pan-European Consensus
Test Substances: Controls and Comparators
Investigational Medicinal Products (IMP) and Good Manufacturing Practice (GMP)
Other GMP Considerations
Support Services: What Standard?
Ethics Committees (IRB) and GCP
SOPs in the Clinical Area
Planned SOP Deviations
Data Protection Act (1988, U.K.) and Freedom of Information Act
Standardized Reports: Regulatory Submissions
Archived Data Disposal
Organization's Policy on Fraud
TRAINING IN THE REGULATED ENVIRONMENT
Training of Laboratory Staff
Laboratory-Based Nonscientific Staff
Training in Data Management
Training of QA Staff
Training for Archivists
Training of Medical, Nursing, and Technical Staff
Training for Medical Staff
Different Training (Learning) Methods for Different Areas?
Assessment of Training Effectiveness - How?
QA Inspection Points
COMPUTING IN THE REGULATED ENVIRONMENT
Before 21 CFR Part 11
IT Systems in Organizations
Validation of Computing Systems
After 21 CFR Part 11
21 CFR 11 - Key Elements
Electronic Records and Signatures
Assistance with Validation and Risk Assessment
Electronic SOPs (E-SOPs) vs. Paper SOPs
Server Backup Considerations
A Suggested Tape Backup/Archive Routine (With 22 Tapes for an Annual System)
E-Mail in the Regulated Environment
E-Transfer of Documents and Signatures
Digital Signatures in Documents
QA and User Authentication to Computer Systems
Definitions of Biometrics
IT Security Considerations
When Do You Carry Out an Inspection?
How Often Do You Inspect?
What Records Should QA Keep?
Checklist of Various Items in a Clinical Inspection
Clinical Inspection Procedure
Long-Term Projects: Data Review Procedures
Personal Research Projects (Non-GxP)
CVs and Training Records
Carrying Out External Audits
Approval Process Smooth QA Operations
Report Audit Procedures
QA Record Keeping
Other Quality Systems: A Brief History
Quality Control vs. Quality Assurance
Responsibilities: QA and Management
Protocols, Contracts, and Quality
Total Quality Management
System Inspection: A Change in Viewpoint
Medics and Management
IT to the Rescue?
The IT Infrastructure Option: The Works
Problems with Electronic Systems
Asset Management: Staff
The QP: An Asset or Liability?
Possible Business Continuity Plan
So You Think You Have a Good Quality System?
How Does the Baldridge System Work?
Defining Your QA Person
Defining Your Quality System
Sponsor Audit Preparation
The Site Master File/Dossier
U.K. GCP Regulatory Inspections
Developing Your Systems
Information Resources and Acronyms
"…provides the reader with a pragmatic approach to the principles governing accepted methodologies within the working environment and provides some useful examples of these interpretational differences across industry."
"…provides a solid foundation as well as tips and techniques for establishing a quality system that will comply with all the relevant regulations."