Importance of Onsite Visits
“An onsite visit is where you meet the potential team members and learn who the company is rather than what it can do for you,” Badal said. Valeant’s team usually includes representatives from its quality assurance, regulatory affairs, and manufacturing departments, as well as the company’s point of contact.
Typically, Valent conducts two site visits for the top contenders, Badal noted. The first visit is simply to get acquainted with the site, to ascertain the age and condition of facilities and equipment, and to get to know the people and their style of operations and communications.
That includes understanding both the regional or national culture and the corporate culture. For example, in a highly hierarchical culture, will a junior associate challenge a senior associate to resolve a potential problem? Will the need to avoid embarrassment cause issues to be handled without input from the client? Synergy between the CMO and the prospective client can alleviate many quality concerns simply because the two organizations will have similar understandings and approaches.
“Experience matters,” Dr. Sabouni insisted. “A Ph.D. with five years’ experience is very different from a Ph.D. with 25 years’ experience in terms of depth of knowledge.” That difference can be very important, particularly when novel compounds are being manufactured.
Dr. Sabouni also recommended working with a CMO whose staff members have experience at both big pharma and small biotechs. Those with large company experience tend to know the regulatory environment better than those with small company experience, simply because they are more likely to have taken several drugs through the approval process.
“They also will have an eye on development issues and the eventual product launch,” Dr. Sabouni said. Those are issues that emerging companies too often overlook in the excitement of pushing the developmental envelope.
On the other hand, he continued, “individuals with small company experience are especially important to biotechs because they know how they think.” They also better understand the need for speed and the financial constraints that can make or break a small company.
The second visit is a quality audit. Typically, Badal said, a team will investigate the CMO thoroughly, examining its internal operations, production floor, equipment, and maintenance records, as well as its scale-up process and capabilities, regulatory affairs track record, and standard operational procedures. “Learn how they handle out-of-spec findings,” Dr. Sabouni suggested.
This is also an opportunity to examine the CMO’s external linkages. “We look at their supply chain and sourcing activities and relationships,” Badal said. “If they’re not strong, you risk hiccups in the future, in terms of quality issues, delays, and delinquencies.”
Some firms (in other industries) will interview the CMO’s suppliers, ascertaining their quality procedures, financial strength, and ability to handle the additional business. Also, the team will determine whether a local or regional disaster to one of the suppliers would halt or significantly slow production, or whether the supply chain is sufficiently broad to adjust to fluctuating conditions.
Badal also recommended using the trip to verify the local reputation of the CMO and its key staff members. “You’re doing a lot of evaluation on the people at this point including calling and checking references.”
Look at past products, too. Dr. Sabouni advised examining a CMO’s regulatory track record. “Were there warning letters or reprimands? How were they resolved? Check their 386 records and the results. When were they last visited?” he asked. Whether the visit was six months ago or six years ago matters. “Were there regulatory issues? Were the products delivered on the expected timeframe, and if not, why? If issues arose during production, could the CMO realistically have been expected to have anticipated and resolved them proactively?”