Biotherapy partnerships with external entities to perform critical services such as the procurement, manufacturing, testing, and administration of a cell/tissue product have become increasingly commonplace. Such relationships are often defined by a Service Agreement and may also include a Quality Agreement. Service Agreements typically outline the scope of services or work to be performed, monetary costs or exchange, and business liabilities. In contrast, Quality Agreements identify key quality and regulatory responsibilities between the client and the service provider(s). The key to the Quality Agreement is to have clear communication of expectations between parties with emphasis on each party having a sense of ownership through mutually agreed-upon language and activities. At a minimum, the Quality Assurance units of all parties should have input into drafting the Quality Agreement, with feedback from the respective institutional contacts (sponsor, procurement facility, processing facility, manufacturing facility, and administration site). This Quality Agreement template is a result of a request by the AABB and ISCT communities for an interpretive tool to assist with development of a Quality Agreement. The template includes suggestions based on 1) regulatory standards for the safety and quality of the product and processes and 2) guidance on Quality Agreements. This template defines the responsibilities of relevant parties regarding Quality Assurance, Quality Control, and Quality Risk Management.
Diane Kadidlo, MT(ASCP), SBB
Project Co-Leader
Facility Director, Molecular and Cellular Therapeutics, University of Minnesota
St.Paul, MN
Sufira Kiran, BS, CQA, MLS
Associate Director of Quality Assurance Research/Manufacturing at UTHealth Science Center
University of Texas Health Science Center, Houston, TX
Aisha Khan, ABD, MSc, MBA
Executive Director Of Clinical Research & Laboratory Operations
University of Miami, Miami, FL
Suzanne Dworsky, BS,CABP(H),MBA, MT(ASCP)
Medicine Department Administrator, Stem Cell Transplantation and Cellular Therapy
MD Anderson Cancer Center
Houston, TX
Diana Nordling
Assistant. Director Quality Assurance
Hoxworth Blood Center
3130 Highland Ave.
Cincinnati, OH
Brenda Alder
MS, MT(ASCP)SBB, CABP(H)
Northside Hospital
4700 Gran River Glen
Peachtree Corners, GA
Mary Grable McLeod, MLS(ASCP)CM SBBCM, SSGB (ASQ), CABP(H)
Project Co-Leader
Quality Manager – Blood and Marrow Transplant Cellular Therapy Facility
Stanford, CA
Jelena Holovati, PhD
Associate Professor, Director, Edmonton Stem Cell Manufacturing Program, Canadian Blood Services
Department of Laboratory Medicine & Pathology
Division of Medical Laboratory Science
University of Alberta
Alberta, Canada
Aleksandra Babic
Senior Manager Quality Assurance
Site Qualification and Regional Operation Quality ACE and International
Kite Pharma a Gilead Company
CapitaSpring, Singapore
Netherlands
William Shingler PhD MBA
Senior Director, Patient and Cell Management
Autolus
London, UK
AABB Representatives
ISCT Representatives
4550 Montgomery Avenue
Suite 700, North Tower
Bethesda, MD 20814
301.907.6977
