Data Integrity and the negative impact on Products Manufacturing
Today more than ever, Data Integrity has become a significant factor in being a compliant...
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Author: Nigel J Smart PhD
Generating efficiency through efficient Laboratory Integration
Laboratory compliance and efficiency can have a major impact on the success of the company to...
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Outcomes from 483 Observations
One of the outcomes from a poorly handled 483 response is that the severity of the enforcement...
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What’s involved with 483 Observations
Upon inspecting your pharmaceutical facility, the FDA will issue a 483-observation report if there...
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Development validation Programs for Biopharmaceutical Companies
The development of a strategy for the commissioning of facility and equipment systems to support...
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Testimonial
Smart Pharmaceutical Consulting has made a major contribution to our manufacturing strategy and how we plan to operate our plant in the future.