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Issue link: https://lifescienceleadermag.epubxp.com/i/183480
Contract Manufacturing Roundtable Kempinski: At least one CMO I work with is engaged with Rx-360 whose stated mission is, "To protect patient safety by sharing information and developing processes related to the integrity of the healthcare supply chain and the quality of materials within the supply chain." Selection of vendors and the ongoing quality oversight required are highly time-consuming processes. Rx-360 has some interesting objectives to establish best practices for auditing standards and the use of expert third parties to conduct audits and authenticate supplies and suppliers. It is too early to categorize this as something being done extremely well or bound to fail, but it is a creative initiative that illustrates some progressive thinking toward improving the efficiency of quality management and compliance oversight of a global supply chain. O'Brien: We recently implemented a new solution to increase our end-to-end oversight for distribution of clinical study supplies. Our prior model was highly decentralized and relied on local in-country Pfizer support to manage key importation activities such as brokerage services, import licensing, and duty and VAT payments/reclamation. Various factors prompted a reassessment of this model, which resulted in the implementation of a centralized solution. Key factors for success in driving this change included aligning the ownership within our existing clinical distribution team and conducting a rigorous supplier selection process to ensure appropriate alignment of skills and expectations. WHAT IS YOUR CMO DOING TO ENSURE SUPPLY CHAIN SECURITY AND INTEGRITY, AND HOW DOES THIS HELP IN ACHIEVING OPEX? Bruno: As a consultant, I work with a number of CMOs. When you start the project and people are already thinking about what could go wrong and where problems exist, this is helpful and makes me more relaxed. Hearing people talking about equipment improvements and how they can reduce the operational time and increase throughput early on is helpful. I recognize that often you have good ideas which do not work. Casebier: Never enough. We know that at the end of the day it is the responsibility of the sponsor to the Agency (e.g. FDA) for the drug. We expect qualification of the primary supplier and identification of alternate suppliers for raw materials and equipment. We expect this of ourselves for our own supply chain. Kempinski: As the supply chain has gained increased dependence on sourcing from emerging regions such as China and India, some CMOs are working together on best practices as a means to obtain and share data regarding the quality and authenticity of supplies/suppliers. Many CMOs hire a local representative to help with vendor selection and real-time oversight, 16 The CMO Leadership Awards 2013 and others open a local office for building trusted relationships. OPEX improvements to control lead-time, process performance, and product quality cannot be achieved without trusted supplies. Additionally, a strong relationship between CMOs and supply vendors is critical to secure a compliant, cost-effective, and reproducible means to deliver quality products. O'Brien: Of course, there is no higher priority than ensuring that consumers are provided safe and effective medicines. As such, we are relentlessly vigilant in our efforts to address threats to supply chain integrity, including counterfeiting, cargo/theft diversion, and economically motivated adulteration of products. We expect our CMOs to partner with us in these actions, and we constantly evaluate our CMOs to ensure that their processes, ranging from site security to core quality systems, are in place and aligned with these priorities. HOW SHOULD A CMO BE AUDITING SUPPLY CHAIN SECURITY? Bruno: The loss of material in the market can be a real disaster for companies and patients. Companies need to audit their supply lines on a regular basis. The audit needs to be looking at the complete supply line as well as the regulatory history of the company. I looked at this as a typical "risk/reward" situation. How great is the risk for each of the raw materials and how can I minimize that risk? Could anyone really predict a volcano erupting and the effect it had on shipping from Europe? Both sides need to understand the risks and how to mitigate them. Kempinski: FDA and EMEA have issued guidelines for risk-based approaches in auditing, qualifying, and monitoring suppliers to assure the integrity of supplies. CMOs should follow these guidelines and tailor an approach based on material criticality, experience with the material and vendor, and compliance history. Based on these categories, audit formats can range from paper surveys to on-site inspections. Material acceptances can transition from a repeat of full release testing to acceptance based on certificate of analysis (CoA), and a one-to-three year audit frequency. It is important for CMOs to stay abreast of emerging trends that may compromise supply chain safety or security. O'Brien: Methods and frequency regarding auditing practices are specific to a given scope of work being conducted by a CMO. On a macro level, we support serialization, electronic pedigree, and track and trace as important safeguards to the pharmaceutical supply chain. Success in these areas requires extensive and open partnerships across the industry (e.g., between pharma companies and CMOs) and more broadly with wholesalers, the pharmacy community, regulations, and law enforcement agencies.