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Standards for Cellular Therapy Product Services, 6th Edition Product Image

Standards for Cellular Therapy Product Services, 6th Edition

  • Published: July 2013
  • Region: Global
  • 130 Pages
  • AABB

The sixth edition of Standards for Cellular Therapy Services details the latest standards of practice for accredited cellular therapy facilities. Significant changes:

- New and enhanced standards that address clinical activities, including but not limited to standards about patient consent, patient care, preparation for administration, and clinical outcomes reporting.
- Restructured Chapter 5 Process Control to divide the chapter into four distinct areas of focus: general process control, procurement activities, processing activities, and clinical activities.
- Expanded non-hematopoietic content addressing elements of novel cellular therapies.
- Several revisions to assist in the international application of the standards.

PREFACE

INTRODUCTION

1. ORGANIZATION
1.1 Structure, Responsibility, and Authority
1.2 Quality
1.3 Emergency Operation Plans
1.4 Communication of Concerns
1.5 Customer Focus
1.6 Human Subjects Research

2. RESOURCES
2.1 Resources
2.2 Human Resources

3. EQUIPMENT
3.1 Control of Equipment

4. AGREEMENTS
4.1 Agreement Development and Review
4.2 Physician Orders
4.3 Agreements Relating to Cellular Therapy Products
4.4 Educational and Promotional Materials
4.5 Informed Consent
4.6 Obtaining Materials, Products, and Services
4.7 Notification
4.5A Informed Consent for Donors
4.5B Informed Consent for Patients

5. PROCESS CONTROL
5.1 Process Control
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 at Processing Facility
5.18 Evaluation to Make a Product Available for Distribution
5.19 Distribution
5.20 Product Issue
5.21 Clinical Program
5.22 Receipt and Administration of Cellular Therapy Products
5.23 Storage at Administering Facility
5.24 Preparation for Administration
5.25 Administration
5.26 Postadministration Monitoring
5.27 Clinical Outcomes
5.7.1A Requirements for Labeling of Cellular Therapy Products
5.7.1B Requirements for Labeling Shipping Containers
5.8.5A Labeling and Packaging Requirements Upon Shipping of Cellular Therapy Products
5.11A General Requirements for Cellular Therapy Product Donors
5.11B Clinical Evaluation and Laboratory Testing of Donors
5.16A Processing Tests for HPC, Apheresis, and HPC, Marrow
5.16B Processing Tests for HPC, Cord Blood Products
5.16C Processing Tests for Cellular Therapy Products Other than HPC, Apheresis; HPC, Marrow; and HPC, Cord Blood

6. DOCUMENTS AND RECORDS
6.1 Document Control
6.2 Record Control
6.3 Electronic Records
6.2.1A Records

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

8. INTERNAL AND EXTERNAL ASSESSMENTS
8.1 Assessments
8.2 Proficiency Testing
8.3 Monitoring

9. PROCESS IMPROVEMENT
9.1 Corrective and Preventive Action Plans

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

Glossary
“Crosswalk” Between the Fifth and Sixth Editions of CT Standards
Index

Note: Product cover images may vary from those shown

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