May 2013

For Pharmaceutical Companies

Avoiding Remediation with a Good QMS

by: Walt Murray, Director of Quality and Compliance Services, MasterControl Inc.

Many companies will try to resolve compliance actions by the Food and Drug Administration (FDA) through the use of an electronic data management system (EDMS) approach that is typically post mortem. This is risky business at two critical levels. First, no EDMS approach will replace the operation of a comprehensive quality management system (QMS) that describes the integration of necessary GxP (compliance) driven quality processes. Secondly, the response will need to have a litany of justifications for a retrospective systematic approach. This is like trying to perform process validation on pre-existing production of unqualified products: it’s bad business!

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SPC vs SQC: The Strategic Difference

by: Jason Orloff, Statistical & Engineering Consultant, Pharmstat

The tension between after-the-fact inspection and defect prevention has been at the heart of manufacture since the introduction of statistical methods to industry in the 1940s. Today, to clearly divide responsibilities within an organization and tie these very different activities to existing roles, consider a division by impact to the patient. Activities which monitor a process in real-time to prevent defects while a lot is being manufactured are known as Statistical Process Controls (SPC).

In contrast, activities which occur after manufacture to keep defects from reaching a patient by additional inspection are Statistical Quality Control (SQC). The difference is one of strategy. From the patient’s perspective, SPC’s feedback during manufacture prevents risk while SQC’s feed-forward guards against catastrophic failure. Both are necessary in an industry of low volume, high cost, high-risk goods.

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Ways to Ensure Supplier Compliance

by: Cindy Fazzi, Marketing Communications Specialist, MasterControl Inc.

Your suppliers are critical to your success. They can increase your company’s efficiency—in terms of time, cost, and quality. But in some cases, suppliers can put their clients in hot water; this is especially true if those clients are regulated companies.

For example, Epimed International, a medical device company, received a warning letter from the U.S. FDA for quality violations involving its supplier. The FDA said in a 2012 warning letter that Epimed conducts acceptance testing on the radio frequency of thermocouple electrodes without knowledge of the device manufacturer’s original specifications from the initial manufacturer, or how changes made to the device (e.g., sterilization cycles) will affect the device.

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