5 Essential Standards for Pharmaceutical Manufacturing


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The pharmaceutical industry encompasses every aspect of medications and drugs, meaning businesses in this industry develop, optimize, produce, and market medications for a wide range of medical conditions, from over-the-counter headache pills to advanced treatments for cancer and other diseases. It is an industry with global revenues around $1.2 trillion USD (IQVIA Institute for Human Data Science) that truly impacts billions of people. 

ASTM International’s committee on the manufacture of pharmaceutical and biopharmaceutical products (E55) was created to address many facets of this expansive field. Formed in 2003, the group addresses issues related to “process control, design, and performance, as well as quality acceptance/assurance tests for the pharmaceutical manufacturing industry.” It works with drug and drug-equipment makers, government agencies, designers, professional societies, trade associations, financial organizations, and those in academia.

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