An industry group has begun work on a quality agreement template for single-use technology suppliers and their customers. The BioProcess Systems Alliance, an organization of the Society for Chemical Manufacturers and Affiliates, has convened the Quality Agreement Template Task Force for the job.
Quality agreements are becoming increasingly important as single-use technology penetrates bioprocessing operations, says Jerold Martin in Pharmaceutical Technology Europe magazine. Martin is chairman for the BioProcess Systems Alliance and a senior VP at Pall. Filters, biocontainers, tubing manifolds and other system parts, he says, have become the subject of quality agreements negotiated on a case-by-case basis between biotech drugmakers and single-use system suppliers. It's time to standardize.
Martin predicts that regulators will eventually come to expect such agreements to be in place. And as far as users are concerned, a templated quality agreement will prove a nice complement to any standard developed to define compatibility requirements for established stainless steel bioprocessing equipment and single‑use systems.
A standard that defines the requirements for compatibility of established stainless steel bioprocessing equipment and single‑use systems, based on agreement between disposables manufacturers and drug manufacturers. So says Mark Kruszynski, a tech transfer engineer at Baxter.
- here's the article