Patrick J. Hanley, PhD, is the Laboratory Facility Director for cellular therapy and stem cell processing at Children’s National Health System. In addition to GMP regulations, Dr. Hanley is interested in improving outcomes after stem cell transplantation, including bone marrow transplant and cord blood transplant. He currently sits on the Immunotherapy committee of the International Society for Cellular Therapy (ISCT) and co-chairs its Early Stage Professionals committee. Since 2013, Dr. Hanley has been a FACT inspector and inspects both cellular therapy and cord blood banking processing facilities. In addition to volunteering as an inspector, he is a member of the FACT Cellular Therapy Accreditation Committee and Cellular Therapy Processing Facility Standards Committee.
Dr. Hanley shares his insights into why he became an inspector, and the benefits he has gained from this experience.
Becoming a FACT Inspector
I became interested in becoming a FACT inspector a bit serendipitously. I noticed a FACT Inspector Brochure in Dr. Catherine Bollard’s office that listed advantages of being an inspector. What I found appealing was the opportunity to travel to some of the most well-known, cutting edge facilities in the world and learn how they function. How do they train staff? How do they qualify critical reagents and handle inventory control?
After verifying my education and experience made me eligible, I asked Dr. Helen Heslop what the first step is to become a FACT inspector. She directed me to the FACT website and the online inspector application. After completing initial training requirements, I performed my training inspection with Dr. Monika Smogorzewska. I found the information obtained through this visit invaluable when we had to develop our own cell therapy facility at Children’s National in 2013. Since my first inspection in 2013, I have performed an average of two inspections per year.
Learning from Inspections
I really look forward to learning new information when I perform a FACT inspection. One of the aspects of the inspection process that I’ve found valuable has been the opportunity to visit other facilities and gather new ideas. For example, I trained at Baylor College of Medicine, which is quite a large academic facility. Our facility at Children’s National is significantly smaller and I am always looking for ways to improve our productivity and make more out of the existing space. I am also looking towards the future to identify aspects of various facilities that I would like to include in the new facility we have planned.
Children’s National has its challenges and areas where improvement is needed, which is no different than other FACT-accredited programs. As an inspector, I have the unique opportunity to see (for FREE) how other institutions handle similar challenges, and hear from others what works and what does not. The staff at Children’s can usually tell when I’ve been on a FACT inspection because I come back with a list of questions and suggestions based on my recent experience. Recently, after returning from an inspection, I asked for our transient warming validation and where we documented the length of time that the product was out of the freezer.
One experience of mine that was striking was while performing a more-than-minimal manipulation inspection at an institution. The site volunteered to show me its Investigational New Drug (IND) Application for one of its clinical trials. We have our own clinical trials, but to see how another group writes their Chemistry, Manufacturing, and Controls (CMC) section of the IND was fascinating. I walked away quite impressed with the effort they put forth qualifying their critical reagents.
Observing Frequent Deficiencies
One deficiency that I have found to be quite common is D4.14, which states that tests must be validated for their intended purpose. Where most sites fall short is that they use the BacT/Alert or BacTec sterility tests that have been validated for whole blood, but not cell therapy products. Another deficiency that is often overlooked is the expiration date of supplies and reagents – especially ethanol and disinfectants.
A standard that I think is critically important that is often cited is the annual report on the progress of the quality program. I think the majority of groups have regular meetings that meet the standard, but they fail to discuss how well the quality program is working, and what the problem areas have been over the past year. Similarly, as more and more programs start to use therapeutic cells (such as donor lymphocyte infusions) or cells under a clinical trial, these protocols are sometimes overlooked and outcomes are not always reported.
Preparing for Inspections
As an inspector, reviewing the documentation as early as possible is an absolute must so that you have the opportunity to request additional information as needed. More and more sites are requesting accreditation for more-than-minimal manipulation, and looking over the documents early provides me with the opportunity to determine what is being extensively manipulated. It also allows me to speak with the FACT office if needed about whether the program meets the criteria or not.
Another suggestion is to reach out to your peers who are inspectors for ideas. My mentor for my recent cord blood training inspection sent me a list of items for which he wanted to request more information from the bank. When he followed that up with a second checklist, it was a very enlightening moment for me; so much so that I scanned the list and saved it to my desktop (thanks Ping!).