The FDA is thinking a lot about quality in manufacturing these days. FDA Commissioner Margaret Hamburg talks about it at public appearances, and CDER Director Janet Woodcock has set up an office dedicated to it. The agency wants drugmakers and their contract manufacturers to give it more consideration as well.
In new draft guidance, the FDA is suggesting that drugmakers and CMOs sign quality agreements, laying out exactly who is responsible for what.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 and all phases of the process from sourcing product to packaging, labeling and testing. Comments are being solicited from the industry through July 29.
The agency has to be considering situations like Bedford Laboratories, the contract manufacturing operation of Boehringer Ingelheim, whose facility in Bedford, OH, has been at the heart of huge drug disruptions in the U.S. The facility is now operating under a consent decree, but it manufactured drugs for scores of companies and if a few of them had raised red flags with the operation, problems at the plant might have been addressed sooner rather than later.
The guidance was issued even as regulators in Canada asked three drugmakers--Cobalt Pharmaceuticals, Laboratoire RIVA and Sanis Health--to voluntarily recall all lots of their antipsychotic product Quetiapine because of regulation lapses by a contract manufacturer in China. European regulators found problems at the Suzhou No. 4 Pharmaceutical Factory, China, that may have allowed the quetiapine API to have been contaminated with clindamycin.
The question of who is liable for quality lapses in manufacturing also recently came up in some warning letters the agency sent to dietary supplement companies, the FDA Law Blog points out. The agency cited the so-called Park Doctrine, when pointing out that the companies are responsible for their CMOs getting manufacturing and labeling correct. The Park Doctrine allows the agency to convict a company official of a misdemeanor if they had the authority to prevent problems, even if they were not directly involved in them.
- here's the draft guidance
- here's the Health Canada release
- read the FDA Law Blog post