In January 2019, FDA Commissioner Scott Gottlieb confirmed through a series of tweets and other statements that manufacturers should expect FDA inspections of generic drug plants to increase and become more thorough throughout the year as part of an effort to implement its "risk-based" inspection model.

According to Gottlieb, the agency has made a concerted effort to inspect every generic facility, which has allowed for "a very sophisticated risk-based model to target future inspections; making our inspectional work more focused, more efficient, and more effective.”

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Life science validation projects –– particularly those in heavily regulated industries like medical device and pharmaceutical manufacturing –– often require a multi-disciplinary team of professionals sourced from internal functional areas as well as outside resourcing firms capable of filling internal gaps and bringing firsthand experience and specialized expertise to bear.

The practice of using multi-disciplinary teams to support Quality System activities including the Qualification and/or Validation of new or modified facilities, systems and processes has become a cGMP expectation of the FDA as well as many other regulatory agencies in ICH markets.

Regardless of the specific type of validation work being done, quality outcomes are increasingly reliant on creating these cross-functional teams that are built and managed in a way that recognizes the abilities, incentives, and limitations of each stakeholder and points them toward the same objective.

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The FDA recently issued its final guidance intended to help the medical device industry determine applicable requirements for making a change to a medical device manufacturing site.

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Many FDA-regulated manufacturers find themselves without the resources or processes to efficiently manage product complaints. When the resulting backlog isn’t cleared quickly and completely, the issue can compound into serious safety and compliance problems requiring many hours of work to resolve.

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Corrective and Preventive Action (CAPA) routinely tops the list of most-cited inspectional observations year after year, making it a clear target for investigators. When problems are found in your CAPA program, it can open your broader QMS up to intense scrutiny.

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