FDA Conference on Regulatory Education for Industry is Next Week
The United States Food and Drug Administration (FDA) is hosting its annual conference, Regulatory Education for Industry (REdI), virtually next week from July 19-23. Register for this free conference to learn directly from senior leadership at FDA. Continuing education credits for several professional organizations are available, and this conference can also be used toward GxP training now required by the eighth edition FACT-JACIE Hematopoietic Cellular Therapy Standards.
For the first time, this conference will have tracks for three medical products: drugs, devices, and biologics. The biologics track will focus on different aspects of product development of advanced therapies regulated by the Center for Biologics Evaluation and Research (CBER). Topics include regulation of tissue products under 21 CFR part 1271; development and regulation of cellular, gene, and plasma-derived therapies, and expedited programs for advanced therapies.
Register for the free, virtual FDA REdI Conference
The X Factor: What is GxP and What Training is Required?
The eighth edition FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration requires that physicians and staff have annual training in current GxP appropriate to the processes performed in accordance with Applicable Law. (See Standards CM3.3.4, C18.104.22.168, and D22.214.171.124).
What is GxP?
The Standards define GxP as, “Good practice following various quality standards and regulations. The “x” is variable, with further definition of good practices defined by different Applicable Law and industry standards. The type of work that is being performed will define which GxPs should be followed.”
Different facilities will follow different GxPs based on the activities they perform. These may include, but are not limited to, Good Manufacturing Practices (GMPs), Good Tissue Practices (GTPs), Good Documentation Practices (GDPs), Good Clinical Practices (GMPs), and Good Laboratory Practices (GLPs).
What GxPs require annual training per the Standards?
FACT requires training in all GxPs that are required by law. Accredited facilities must determine which GxPs apply to the activities they perform and for the types of cellular therapy products for which the cells will be used. This includes an assessment of all activities and determination of which GxPs are required by law for each of those activities. Facilities must document this assessment so 1) the program has a defined list of GxPs that require training and 2) inspectors can verify appropriate training is performed.
All Apheresis Collection and Processing Facilities will have activities applicable to GTPs and GDPs. All Marrow Collection Facilities will have activities applicable to GDPs, but may also perform activities related to GTPs. Collection and Processing Facilities may also need to follow GMPs, GCPs, or GLPs. The extent and level of GMPs implemented is dependent on the type of manufacturing that is performed (e.g., manufacturing of allogeneic minimally manipulated HPC cellular therapy products verses investigational and licensed cellular therapy products).
How much training is required each year?
Comprehensive training on every aspect of GxPs each year is not expected; rather, there must annually be some training based on a GxP topic.
Many of the procedures performed by personnel already require training in GxPs to perform the work; therefore, GxP training is not required to be separate. However, documentation must provide evidence that the GxPs were included. For example, training in environmental control could include an overview of GTPs or GMPs, the relevant requirements based on the work to be performed, and the specific tasks performed by personnel.
Download the Eighth Edition FACT-JACIE Hematopoietic Cellular Therapy Standards
Download the Eighth Edition FACT-JACIE Hematopoietic Cellular Therapy Accreditation Manual
Data Management Resources Serve as Gateway to Improving Reporting
By Heather Conway, FACT Quality Manager
To assess compliance with FACT standard B9, the FACT-CIBMTR Data Audit Committee reviews each program’s most recent CIBMTR data audit results including implementation, adequacy, and effectiveness of the corrective action plan (CAP). The committee’s goal is to provide education and assistance to cellular therapy programs throughout the accreditation cycle to achieve quality improvement in data management. At the time of accreditation renewal, the FACT Accreditation Committee assesses the completeness and accuracy of a program’s data management based on the clinical inspector’s report and the report of the FACT-CIBMTR Data Audit Committee.
Since its inception, the committee has provided extensive guidance and assistance to programs regarding data management, audit, and quality improvement principles. Using this experience, the committee created a Data Management resources area to assist programs. Programs are encouraged to review this information, which contains CIBMTR resources, FACT educational resources, guidelines for data management submissions, templates, and examples.
The FACT-CIBMTR collaborative data audit process was formed to reduce duplicative efforts, enhance quality improvement efforts, and provide support to accredited transplant programs. The program intensifies support and improvement of data management and reporting processes, and these new resources support these efforts. In addition to the website, view previous newsletter articles about the program:
FACT and CIBMTR Announce Joint Data Audit Program
The Role of Medical Records During On-Site Clinical Program Inspections
Transporting Cellular Therapy Products Intended for High-Dose Chemotherapy Recipients
The FACT-JACIE Hematopoietic Cell Therapy Standards state, “If the intended recipient has received high-dose therapy, the cellular therapy product shall be transported.” (CM10.3.2, C10.3.2, D10.7) Some have asked what the purpose of this standard is because a product always needs to be distributed to the recipient.
The key word in this standard is “transported.” As stated by the FACT-JACIE definitions in Part A of the Standards, “transport” is the physical transfer of a cellular therapy product within or between facilities during which it does not leave the control of trained personnel at the transporting or receiving facility. In other words, someone who is trained to transfer a product must be with it at all times. This is in contrast to shipping, during which the product does leave the control of trained personnel (such as shipment on a commercial distributing company’s truck or airplane).
If a patient has undergone high-dose marrow ablative treatment in preparation for transplant, the cellular therapy product is essential for the patient’s survival since it may not be possible to obtain additional marrow or blood from the original donor or a second donor in time to prevent complications from aplasia. For this reason, it is important that the product be entrusted to a knowledgeable individual who accompanies it from the distributing facility to the receiving facility.
AHCTA Publishes Analysis of Processing Staff Training and Competency Assessment Practices
The Alliance for Harmonization of Cellular Therapy Accreditation (AHCTA) surveyed cell processing facilities worldwide to elicit information about their training and competency assessment programs. Because these programs are critical to the safety of hematopoietic progenitor cell (HPC) products, the survey results are a resource to facilities to establish and maintain a competent workforce.
Results were published in Cytotherapy in Training practices of cell processing laboratory staff: analysis of a survey by the Alliance for Harmonization of Cellular Therapy Accreditation (Taylor, Slaper-Cortenbach, et al, Dec 2015, doi:10.1016/j.jcyt.2015.08.006). Respondents to the survey represented a diverse set of processing facilities and answered questions related to their facility type, location, activity, personnel, and methods used for training and competency.
Data from the survey illustrated a variety of training and competency methods, with some being more common than others. The results may help processing facilities with establishing or improving their training and competency programs.
Qualification in Apheresis (QIA) Credential Now Available
The American Society for Apheresis (ASFA), in collaboration with the American Society for Clinical Pathology (ASCP), now offers a new credential in apheresis medicine.
The Qualification in Apheresis (QIA) is offered through ASCP and follows the Hemapheresis Practitioner (HP) and Apheresis Technician (AT) certifications. QIA certification expands credentialing for apheresis medicine professionals. There are specific eligibility routes that must be satisfied, including an eligibility route for international professionals.
The 50-question exam covers six areas: Basic Science; Clinical Applications; Donor/Patient Care; Instrumentation; Operational Considerations; and Standards, Guidelines, and Regulations. The qualification is valid for three years, and requalification requires participation in continuing education.
For more information on eligibility routes and available resources, visit the Qualification in Apheresis (QIA) page on the ASFA website.