In an industry where materials are globally sourced, qualifying the raw materials that go into producing a pharmaceutical
product can be complex. Dave Backer, senior director and general manager at SAFC's Carlsbad, CA facility, and Mike Garrett,
senior director, global marketing at BioReliance, spoke to BioPharm International about sourcing and risk mitigation for raw materials.
Photo Credit: Oxford/Getty Images
SOURCING RAW MATERIALS
BioPharm: It's now a global sourcing market for raw materials, presenting problems for manufacturers in ensuring a safe and secure
supply chain. What industry initiatives are in place to ensure supply-chain quality?
Backer: SAFC is in the business of providing raw materials or services to the API market, both for small molecules and biologics.
We recognize that there are two factors that have to be considered in the supply chain and for the raw materials that go into
that supply chain. The first is: can the raw material be made correctly to begin with, and what does that mean? What is the
level of quality of products that go into the supply chain? The reality is that some of these raw materials are made in large
volumes for other industrial applications, of which the biologic or chemistry use is a small part of the total.
The second issue is where was it made? Determining where something is made is much more difficult than it sounds, and requires
knowing, whatever that chemical is, that we've gone back to the source of manufacture and we've qualified that supplier. SAFC
has initiated a program called PharmaGrade. It's a portfolio of products where we say that, for these products, we will confirm
that we know exactly who the manufacturer is, that we've done quality audits, and that it's made appropriately for pharmaceutical
manufacturing. There are other companies that are doing the same. EMD Millipore, for example, has the Emprove program, and
some other companies are going down that path as well. For us as an industry, as suppliers, it becomes more evident that we
have to hit a certain bar. Pharmaceutical and biotech companies are depending on suppliers to be able to provide them with
products that are appropriate.