Compare Pharmaceutical Companies Regarding Quality Management Research Paper

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Quality Management in Pharma

Comparing Pharmaceutical Companies' Quality Management Processes

Comparing the Quality Management processes of global vs. domestic pharmaceutical organizations yield significantly different results. The two companies included in this analysis include Johnson & Johnson, a global leader in the pharmaceutical industry and Mylan, a domestic producer of generic drugs. Supplier quality management strategies of each follow a comparable framework that includes reverse logistics which enables traceability (Kumar, Dieveney, Dieveney, 2009). Both companies are also continually evaluated by the Food & Drug Administration, which has the approval of the federal government to launch onsite audits, unannounced, any day of the year (Murray, McAdam, 2007). Quality management and compliance are critical for risk reduction, not just from a governance standpoint but from an operating expense reduction one as well (Fiscus, 2009). The process of traceability, which is critical for quality management and compliance, is compared between these two firms.


The following diagram provides a process-based analysis of traceability. The functional areas of an organization are listed as rows, with the traceability process defined by specific steps. Figure 1, Traceability Process Workflow, illustrates how collaborative and integrated the entire traceability process is within a pharmaceutical producer. This level of integration is critical from a process standpoint as government-defined quality standards require traceability throughout any pharmaceutical organizations' supply chain (Murray, McAdam, 2007).

These process steps vary in terms of their depth and global scalability by the two companies included in this analysis. For Johnson & Johnson, the need for managing global traceability and recalls is critical, and as a result their distributed supply chain management systems and manufacturing centers have upstream traceability procedures defined while Mylan does not. Upstream traceability for Mylan is not necessary as they are a generic drug manufacturer and rely on a direct sales force. Johnson & Johnson also has automated the supplier batch traceability function and is piloting the use of Radio Frequency Identification (RFID) to more efficiently manage their supply chains (Hook, 2010). Mylan is not planning on adopting RFID for warehouse management, and is instead concentrating on regulatory compliance and reverse logistics. Mylan is also defining supplier quality management metrics of performance and has invested heavily in supplier audits and Six Sigma quality management.

Figure 1: Traceability Process Workflow

Sources: (Connolly, 2007) (Hook, 2010) (SAP Practice on Life Sciences Supply Chains)

Mylan sees themselves as a process goods producer in the pharmaceutical industry while Johnson & Johnson has a more diverse series of products and divisions, with 57% of total revenues in the last fiscal year from pharmaceuticals. Due to this difference in their business models, raw materials and components supplier auditing, a key functional areas of the traceability process, is much more diverse and requires even greater auditing than the comparable process within Mylan. Johnson & Johnson must also be very vigilant regarding how quality impacts their corporate and product brands while Mylan is often labeled as a generic drug by distribution outlets… [END OF PREVIEW]

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APA Format

Compare Pharmaceutical Companies Regarding Quality Management.  (2010, June 12).  Retrieved January 20, 2020, from

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"Compare Pharmaceutical Companies Regarding Quality Management."  12 June 2010.  Web.  20 January 2020. <>.

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"Compare Pharmaceutical Companies Regarding Quality Management."  June 12, 2010.  Accessed January 20, 2020.