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Standards for Cellular Therapy Services, 7th Edition

  • ID: 3623049
  • July 2015
  • 154 pages
  • AABB
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The seventh edition of Standards for Cellular Therapy Services details the latest standards of practice for accredited cellular therapy facilities.

Significant changes to the 7th edition include:

- Donor and patient informed consent requirements have been separated to provide more focused standards; this includes the expansion of Reference Standards 4.5A and 4.7A.
- Enhanced Chapter 5 Process Control to divide the chapter into four distinct areas of focus: general process control, procurement activities, processing activities, and clinical activities.
- New standards requiring specific time intervals depending on the nature of storage devices have been added in Standards 5.10.3.1 and 5.10.3.2.
- Standards relating to in-utero and ex-utero cord blood collections have been added to the 7th edition to assist users as it relates to product labeling.
- Donor evaluation standards focused on clinical activities have been added to this edition in Standards 5.24.1 – 5.24.1.2.

Note: Product cover images may vary from those shown
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PREFACE

INTRODUCTION

1. ORGANIZATION
1.0 Organization
1.1 Executive Management
1.2 Quality
1.3 Emergency Operation Plans
1.4 Communication of Concerns
1.5 Customer Focus
1.6 Human Subjects Research

2. RESOURCES
2.0 Resources
2.1 Human Resources
2.2 Access to Ancillary and Direct Patient Care Services

3. EQUIPMENT
3.0 Equipment
3.1 Elements of Control
3.2 Qualification of Equipment
3.3 Equipment Monitoring and Maintenance
3.4 Equipment Traceability
3.5 Information Systems

4. AGREEMENTS
4.0 Agreements
4.1 Agreement Review
4.2 Changes to Agreements
4.3 Agreements Relating to Cellular Therapy Products
4.4 Educational and Promotional Materials
4.5 Donor Informed Consent
4.6 Authorization for Cadaveric Donors
4.7 Patient Informed Consent
4.8 Obtaining Materials, Services, and Cellular Therapy Products
4.9 Notification

5. PROCESS CONTROL
5.0 Process Control
5.1 General Elements
5.2 Process and Procedure Development and Change
5.3 Quality Control
5.4 Materials Management
5.5 Methods and Operational Controls
5.6 Product Identification and Traceability
5.7 Labels, Labeling, and Labeling Controls
5.8 Transport and Shipping
5.9 Inspection and Testing
5.10 Storage and Preservation
5.11 Donor Evaluation
5.12 Medical Management and Emergency Care of Donors
5.13 Procurement
5.14 Procurement Endpoints
5.15 Packaging
5.16 Processing
5.17 Storage of Noncryopreserved Products
5.18 Cryopreservation
5.19 Expiration Dates and Stability of Products
5.20 Discard and Disposal
5.21 Evaluation to Make a Product Available for Distribution
5.22 Distribution
5.23 Product Issue
5.24 Clinical Program
5.25 Medical Orders for Administration
5.26 Medical Orders for Clinical Care
5.27 Preparation of the Patient for Administration of Cellular Therapy Products
5.28 Receipt of the Product and Storage
5.29 Administration
5.30 Postadministration Monitoring
5.31 Clinical Outcomes

6. DOCUMENTS AND RECORDS
6.0 Documents and Records
6.1 Document Control
6.2 Record Control
6.3 Electronic Records

7. DEVIATIONS, NONCONFORMING PRODUCTS OR SERVICES, AND ADVERSE EVENTS
7.0 Deviations, Nonconforming Products or Services and Adverse Events
7.1 Deviations
7.2 Control of Nonconforming Products or Services
7.3 Adverse Events
7.4 Reporting

8. INTERNAL AND EXTERNAL ASSESSMENTS
8.0 Internal and External Assessments
8.1 Internal Assessments
8.2 External Assessments
8.3 Management of Assessment Results
8.4 Proficiency Testing
8.5 Monitoring Clinical Activities

9. PROCESS IMPROVEMENT
9.0 Process Improvement
9.1 Corrective Action
9.2 Preventive Action
9.3 Performance Improvement

10. SAFETY AND FACILITIES
10.0 Safety and Facilities
10.1 Safety
10.2 Facilities
10.3 General Operational Controls

GLOSSARY

INDEX

Note: Product cover images may vary from those shown
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Note: Product cover images may vary from those shown

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