Virtual companies need to work closely with vendors to get the right quality assurance (QA) procedures in place. That’s according to Dawn Speidel, a director at Latham BioPharm Group.
Speidel says that a growing number of companies have no in-house capabilities. Instead, their manufacturing is outsourced to a series of vendors. She warns that the registered company remains legally responsible for any safety issues.
“[Even if manufacturer A] makes the product […] you remain liable, so you need to make sure you have robust QA in place,” she points out.
Focused on developing product
Virtual companies can sometimes overlook QA, she continues, because they’re established by a small number of founders who are focused on developing a product. Alternatively, companies can be too obsessed with overly stringent QA at an inappropriately early stage, she adds.
“For a preclinical phase with animal toxicity [studies], you don’t need to worry about [product] recall [for example] because the [product] isn’t meant for patients,” according to Speidel. “Start developing training on how to understand the SOPs, including who is responsible for what. This is especially important in virtual companies where everyone wears different hats.”
SOPs will become more complex over time, she notes, as companies move through Phase I to later stages in clinical trials. “There are more regulations to adhere to as you increase the patient [population] size.”