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Tag: drugs

Why Regulatory Compliance Cannot Be an Afterthought in Pharmaceutical Facility Design

There is a pattern that repeats itself across pharmaceutical facility projects more often than it should. A facility is designed, built, and equipped. The project team is satisfied with the result. Then the regulatory inspection happens, and the gaps emerge. Airflow patterns that do not meet cleanroom classification requirements. Documentation systems that cannot support audit…

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How to Set Up a GMP Compliant Pharmaceutical Manufacturing Facility

Introduction: Getting Your Foundation Right From Day One For first-time pharmaceutical entrepreneurs, setting up a manufacturing facility is the most complex, high-stakes project they will undertake. Unlike most industries, pharmaceutical manufacturing operates inside a framework of non-negotiable standards where a single compliance gap can prevent a product from reaching the market entirely. GMP, Good Manufacturing…

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