Managing Expectations and Deliverables: A CMO Roundtable - Pharmaceutical Technology

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PharmTech

Latest Issue
PharmTech Europe

Managing Expectations and Deliverables: A CMO Roundtable
Leading CMOs share their experiences with regard to client expectations and performance indicators as well as strategies for adapting to the changing contract-manufacturing environment. This article is part of the 2010 Outsourcing Resources special issue.


Pharmaceutical Technology
Volume 34, pp. s46-s55

Considering new challenges

PharmTech» Given recent industry concerns in supply-chain integrity, can you explain what additional criteria you may use to evaluate suppliers of raw materials or other ingredients (e.g., increased audits, additional testing)?

»Jenkins (Abbott): We have an extensive program to evaluate raw-material suppliers. We gather information from supplier questionnaires and conduct on-site facility audits. Suppliers are automatically a part of our Supplier Excellence program, which involves monthly evaluations. If there are any issues or concerns, an RCPS session is held.

»Dixon (Baxter): Baxter takes a strong position and stance in ensuring that quality raw materials are used in production processes. The quality-by-design (QbD) approach emphasizes a more careful examination of the quality of our raw materials and raw-material suppliers. This industry trend will only continue as we see more companies involved in the complex pharmaceutical supply chain. Specifically, we use a variety of measures and analytical techniques to assess raw materials received at our facility. Raw materials go through rigorous, predefined testing procedures, including appropriate compendial testing to ensure consistency in raw-material performance.

Based on our preemptive actions on quality standards for our external vendors, we have been able to further improve a strong supplier–quality process. Baxter recently implemented a Global Supplier Quality Plan to ensure that suppliers meet rigorous global quality criteria. The plan is supported by supplier audits and quality agreements between the supplier and Baxter, which enable Baxter to determine and maintain the quality of goods. This global system also enables Baxter to share knowledge across the entire organization as it relates to raw materials and vendor-supplied goods.

The improvements to our supplier-quality plan have led to continuous improvement and better customer service. By using the mentioned techniques previously described, we are able to better understand the cycle time and throughput capability of our planning processes, which enables us to accommodate unanticipated client requests.

»Kosko (Pfizer): Pfizer remains extremely active in the area of supply-chain integrity. Even before the most recent concerns about economically motivated adulteration, Pfizer had an aggressive process in place to effectively evaluate and select suppliers, raw materials, and packaging. That process includes assessments of supplier technology and capabilities, operational and manufacturing capacities, and investments. We also evaluate quality processes, systems, procedures, and compliance to current good manufacturing practice as well as supply-chain practices that include supplier selection and quality management.

»Alberstetter (Vetter): Vetter's quality system includes regular supplier audits and a thorough incoming inspection process. API-related raw materials often are supplied by our customers. Methods are selected or developed separately depending on the product.

We respond to customers' demands by applying security measures such as defined and documented interfaces within the process. Vetter Solutions develops packaging components that support anticounterfeiting measures, including tamper-evident closure (Vetter-OVS). We also apply other available solutions based on customer needs.


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FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
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