Entries Tagged 'GMPs' ↓

Human Tissues: Never Trust, Always Verify

On October 13, 2009, the FDA posted on its website a news release from the U.S. Attorney concerning a California man who on multiple occasions falsified records related to the suitability of human tissues for clinical use.  This is unfortunately just one example of problems with those supplying human tissues.  Follow this link to the FDA’s website to see recalls involving human tissues. I find this personally disturbing on a number of levels, particularly given the important role donated human tissues play in addressing a number of medical conditions and the generally low level of donation of tissues and organs.  Reports such as these, certainly can’t help those striving to improve the rates of tissue and organ donation.

Since many regenerative medicine products utilize cells and tissues as ‘starting materials’ to create new medical products, this news release should remind all of us to never assume the cells or tissues you are using are suitable, unless you have reviewed the documents and verified they meet the donor eligibility requirements under the FDA’s good tissue practice (GTP) regulations.  Of course verifying the quality of materials should be done for all components used in the manufacturing process, but additional emphasis must be given to human or animal origin materials.

It would be ‘nice’ if you could trust your suppliers from the very beginning, but unfortunately, there are unscrupulous individuals who are either ignorant of the requirements, or just don’t care.  Fortunately, there are an increasing number of ‘quality aware’ suppliers for the regenerative medicine field. Our task to always think about the patients who may receive our products and to ensure that the materials used to create them are of the highest quality possible.


New FDA Proposed Rule will Impact Regenerative Medicine Products

For those involved in creating regenerative medicine products that combine cells with various biomaterials, such as natural or synthetic scaffolds, you should be aware that the FDA recently issued a new Proposed Rule for these types of medical products.  In regulatory speak these are “combination products” since each component can be regulated separately.  For example, cells are regulated as biological products and most scaffolds are regulated as medical devices. So a regenerative medicine product consisting of cells and scaffolds is defined by the FDA as a biologic-device combination product.

The new Proposed Rule describes in somewhat confusing detail when the drug-biologic good manufacturing practice (GMPs) will apply to these products versus the medical device quality systems regulations (QSRs).  In a nutshell, the manufacturer of a combination product can decide to either adopt QSR regulations or adopt GMP regulations for the manufacturing or choose a hybrid approach.  Here are the 3 main choices i gleaned from my quick read of the rule:

  1. If you already have a quality system based on the medical device QSR regulations you can continue to use this system.  However, you may need to augment your quality system to include some GMP specific requirements.
  2. If your firm already has a quality program based on the GMPs, you can continue using the GMPs, but may need to augment some elements of the medical device QSRs that are missing.
  3. The alternative either of those approaches is to apply medical device QSRs to only the medical device component and GMPs for the biologic component.  For example, if your regenerative medicine product consists of ex vivo expanded cells that are seeded onto a synthetic scaffold, one could envision a hybrid quality program that ensures the cells (biological product) are manufacturing according to GMPs and the scaffold would be manufactured according to medical device QSRs.

One issue that is not entirely clear, particularly for a regenerative medicine product, is how the designation of a “Lead” FDA Center will influence the choice in the quality approach that is most appropriate.  The “Lead” FDA Center is the group that will review and ultimately approve the medical product.  While there are a lot of similarities between QSRs and GMPs, I’m not sure I would want to choose the QSRs if my combination product is going to be reviewed by CBER, which is more familiar with the GMPs.  Similarly, choosing the GMPs for a combination product that is reviewed by medical device reviewers in CDRH, would probably not be a wise decision.

Like any new proposed rule, I am sure there will be a number of comments from stakeholders in industry and academia. If you want to make a comment on this proposed rule, here is the link to do so online.  Comments are due by 22-December 2009.