Take a good look at your QA and QC ranks as the drug business continues its global spread. The increasingly complex regulatory environment may cast them in a less-than-favorable light.
Drugmakers are taking note and boosting their quality management teams in response to a more challenging regulatory climate, says Chemical & Engineering News.
Eli Lilly ($LLY), for one, has been adding chemists and engineers to its QC and QA areas at its parenteral QC labs in Indianapolis in response to an increasingly demanding FDA, the story says. Both hiring and transfers are being used to meet the need. Portola Pharmaceuticals notes companies having products in the pipeline are unlikely to downsize on the development end, which is where QC and QA scientists are fundamental.
Genentech, a part of Roche has also given the quality department a boost. It's been hiring chemists, biochemists, biologists and other scientists as quality product stewards (QPSs).
Stewards are the point of contact for managing all clinical QC and QA functions on the chemical, manufacturing and control project teams, the story says. Some 15 people now work in the QPS role at the company. Their focus is raw materials, environmental monitoring, in-process testing, drug product testing, viral and mycoplasma testing, quality documentation and QA.
Genentech says QPSs can provide "new, quicker-to-the-clinic approaches to development," according to the story, and ensure that product quality meets predefined requirements.
- here's the story