At a time when the FDA is urging drugmakers to work more closely with contractors on quality, Roche ($RHHBY) says it is already doing it.
Jean-Jacques Kielwasser, who oversees contractors for the Swiss drugmaker, said that the company now has what it calls its Sterile Oversight Strategy (SOS) to insure that its partners are meeting Roche's high expectations, reports in-PharmaTechnologist.com. He was speaking at the Global Pharmaceutical Contract Manufacturing (GPCM) conference in London.
The elements of the SOS include having a Roche person in each contract facility. It also has its own guidance for what it expects in terms of plant management, environmental control, equipment reliability and what is to be done in case of a plant shutdown.
It also has software that allows it to get regular updates on reliability rather than waiting for monthly reports. This Performance Reliability Tool allows Roche to get a closer look at the contractor's compounding, filtration, aseptic filling and labeling processes. Roche will tell them to destroy batches that do not hit its standards. The cost of dumped batches is split between Roche and the contractor depending on the contract and the cause of the problem.
Such strict oversight costs money, and so Kielwasser told in-PharmaTechnologist.com that Roche is reducing the number of contractors it is using. He also said that while these expectations also mean more expense for its partners, they are willing to take it on to get the benefit of Roche's expertise.
The Roche approach is even a step up from suggestions by the FDA on how drugmakers and contractors should work together to ensure quality. The agency last month put out new draft guidance suggesting that drugmakers and CMOs sign quality agreements, laying out exactly who is responsible for what. This way, drugmakers know they can't plead ignorance if a contractor messes up when the drugmaker should have been auditing their work, and contractors can't ignore cGMP rules just because the drugmakers would prefer they skirt the rules to save money. The new guidance provides suggestions rather than mandates for agreements to be applied to all levels of production, from APIs to finished products. It also includes all phases of the process from sourcing product to packaging, labeling and testing. Comments are being solicited from the industry through July 29.
- read the in-PharmaTechnologist.com story