What Should You Look For When Auditing A CMO?

By Ed Miseta, Chief Editor, Clinical Leader

Veda Walcott, VP of Quality, Cook Pharmica

Veda Walcott is no stranger to audits. As the VP of quality for contract manufacturer Cook Pharmica, she often hosts clients performing their annual manufacturing audits of the Cook facility. Last year her company hosted more than 40 such visits by its clients or their partners, and she believes it is only a matter of time before the organization is accommodating at least one audit per week. In her position as VP of quality, Walcott reviews every audit response that goes out. This has made her a bit of an expert on manufacturing audits. She was willing to share some of her insights on the importance of audits in the contract manufacturer selection process.

“In contract manufacturing, the quality aspects of manufacturing go hand-in-hand with customer service,” she says. “When you are audited this frequently, you can’t help but embrace the constant feedback you are receiving. It is this feedback that helps us to ensure we will not only meet the client’s needs, but regulatory requirements as well.”

When planning for your audit, Walcott recommends that you allow two to three days for completion. At a minimum the audit should entail a tour of the facility and a review of internal policies and procedures. “Clients are generally looking for gaps in the system and providing us with their observations,” she says. “In doing so they are attempting to learn the quality systems we have in place at our site, to see if they will marry up well with their own internal quality system. They need to understand what the notification periods are for deviations, and what the master batch record review and approval process looks like.”

 

Leave It To The Most Qualified

The quality of your audit team will determine the success of your audit. Walcott has seen her share of audits where individuals come in and simply go through the motions. “They are just checking boxes and trying to get the audit done as soon as possible,” she says. “Oftentimes the auditors may not be close enough to the process or have the technical understanding that it takes to be an effective auditor.”

Walcott has seen a variety of different personnel performing the audits, but believes company executives typically are the last persons you should have perform the audit. “Ideally, you want to send in personnel who are, first and foremost, familiar with quality systems and control, and second, have the technical background to aid in the assessment of the people, processes, and facility,” she says. “The majority of the auditors we see are from quality assurance and have specialized in auditing manufacturing sites. The outcome of these audits can  influence the contract manufacturer selection process and assist in the quality agreement negotiation, so they should always be left to personnel well versed in the conduct of them.” 

When selecting personnel to perform an audit, Walcott recommends being very selective in the process. Don’t be too quick to select someone who has the right title or seems to have the correct educational background. “The decision should really come down to auditing skills,” she says. “The best audits I have seen are the ones performed by the folks who live and breathe the process. They have been in the industry long enough to understand good quality systems and know where to look and what questions to ask. Always select those folks who have the most experience, regardless of their title or tenure with your company. Auditors should also be very skilled in dealing with people and able to facilitate what can sometimes be a very stressful situation.”

 

Evaluate Their Response As Well As Yours

Once an audit is complete, Walcott recommends providing your contract manufacturer with a report as soon as possible, but no later than 30 days past the examination. The report should detail both major and minor observations. Cook would then provide their response to the findings, also within a 30 day window. “The response received from a CMO is something that sponsors need to take a close look at when selecting a manufacturer,” she says. “It is one of the most important items you can look at when evaluating the culture of quality in the operation.”

The purpose of the response should be to alleviate concerns the client might have. While it is not standard industry practice to respond to client comments (concerns that were not elevated to an observation), she believes responding to comments is a form of customer service and should be considered by all contract firms. Those comments, while not observations, are still an additional way for companies to communicate expectations and identify areas for improvement. “We will always look at each of those comments seriously and decide whether or not we need to make a change or provide clarification,” she adds. “Your CMO should have a team that works full time on hosting and facilitating audits. They should work closely with department managers to produce audit responses in a timely fashion. Someone at the contract manufacturer should also review every response that leaves the company to ensure someone doesn’t promise or commit to anything that does not make sense for the organization or risks impacting other clients’ work within the facility.”

 

CMO Post-Audit Evaluations Are Critical

When the audit is complete, two things should happen. You should evaluate the CMO and decide if they are a good fit for your company. But the CMO should also be evaluating you, to see if your business is a good fit for their company. Walcott believes many CMOs that are anxious to get new business do not always perform their own thorough quality and business evaluation. This can lead to unexpected problems down the line if not carefully evaluated.

Cook performs a cross-functional, new-product evaluation for each new client project to assess the impact to each area of the company. Walcott notes this is for the benefit of the client as well as Cook.

“This initial evaluation incorporates a technical, quality, and regulatory review for each new product,” says Walcott. “The information the client provides through their technical package and audit interactions is critical to putting together the new product assessment. We want to make sure our processes and facilities are capable of handling the safety aspects of any new active ingredient, and we can support the quality and regulatory requirements for the client’s project. Your CMO should always make sure they are able to do a job right. If not, it will be to everyone’s benefit for them to pass on it. The new product assessment process has to be where the business aspects and the quality aspects of the job come together. Following these steps should ensure a good fit between the companies for the respective project you are evaluating for outsourcing.”