Supply Chain Risks
“The biggest risk for cGMP supply chains is qualifying, maintaining, and monitoring suppliers and their raw materials,” according to Chris Duffy, vp of operations at Althea Technologies. To ensure transparency with clients regarding their raw materials, “we must perform due diligence to qualify our suppliers and determine the real manufacturer of the material and where the manufacturer is located.”
Althea’s supplier assessments are based on cooperation between supply chain and quality departments “to identify potential suppliers, evaluate the product portfolio to determine whether the supplier can meet Althea’s needs, and perform the qualification process.”
Its three-pronged approach includes a comprehensive cGMP supplier questionnaire, an on-site audit by a qualified cGMP auditor, and a transmissible spongiform encephalopathy/bovine spongiform encephalopathy (TSE/BSE) statement for all materials used by Althea for GMP activities approved and on file.
“After a supplier is qualified, a change-control agreement is set up. Whenever there is a change in the supplier’s material—including packaging changes, manufacturer’s location changes, product discontinuation, etc.—the supplier must notify Althea in writing,” Duffy continues.
“Reacting to supply shortages in the face of an uncertain demand is another challenge,” Duffy says. “As a contract manufacturer, you have to make a calculated decision to hold more inventory than necessary to satisfy the current demand to react to unforeseen shortages.”
Lean Six Sigma
Mark Bell, vp, site operation, Gallus BioPharmaceuticals, says the economic and technical rationale for Lean operations are the same for any producer of biopharmaceuticals. Lean Six Sigma methodologies focus on removing variation from processes to improve efficiency and quality, using the customer’s definition of quality.
The impetus to integrate Lean Six Sigma into operations includes such global issues as constrained access to capital, pricing competition among CMOs, public scrutiny of healthcare costs, as well as the immediate concerns of optimizing each process to run as efficiently as possible. “Lean provides standardized methods in both development and manufacturing to keep costs under control and projects on schedule while potentially improving quality,” Bell explains.
Implementing a Lean approach relies upon standardization. “Deploying standardized approaches provides tremendous efficiency to everyday work,” he adds, particularly in terms of building more efficient report formats, protocols, and communications technology. “Products and processes are unique, so the goal is not to press a customer into a predetermined mold, but to create a Lean approach that engages the customer.
“Producing cost-effective drugs rapidly ultimately determines a CMO’s success,” Bell notes. “If Lean systems and technology are part of the CMO culture, these methodologies can deliver tangible savings to the customer measured in time, cost, and product quality. As an example, our Condo model lowers the barrier to the cost of manufacturing GMP biopharmaceuticals by reducing up-front capital for facility and equipment, with a rapid point of entry.”
Lean strategies can succeed even if they are only implemented at the CMO, Bell says. “The ability to share and engage in Lean methodologies is more powerful when the two parties engage together, but both parties can benefit even without the client’s active engagement.” Maintaining a Lean culture requires alignment among all of the internal stakeholders—quality, cost, development, operations, sales, and marketing.
Steve J. Evans, marketing manager and business development for Butterworth Laboratories, a contract analytical lab, says the main benefits of outsourcing involve costs, overflow capacity, staffing, and impartiality. CMOs and functional service providers also have the advantage of deep expertise in a broad variety of tests and processes, thereby enhancing productivity and helping improve accuracy.
Disaster recovery is an additional potential benefit. “It’s unusual to find a laboratory (or manufacturing facility) that is overstaffed and that has excessive instrumentation,” Evans says. When routine operations are disrupted, most facilities will suffer. Projects that have been outsourced beyond the involved region or that rely upon a different mix of suppliers, however, may be unaffected.
“Working with a contract facility should be considered a partnership to achieve best results,” Evans stresses. He advises organizations considering outsourcing to not only evaluate GMP/GLP status, available services and techniques, accurate results, and the ability to meet deadlines, but also their demonstrated communications ability, staff expertise, customer focus, and trustworthiness.