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EudraLex - Volume 4 - Good Manufacturing Practice
EudraLex Volume 4 outlines the EU's Good Manufacturing Practice (GMP) guidelines for human and veterinary medicinal products. It covers essential topics such as pharmaceutical quality systems, personnel requirements, premises and equipment, production processes, quality control, and product recalls.
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It also includes specific guidelines for active substances, investigational medicinal products, advanced therapy medicinal products, and various annexes detailing standards for different product categories, including sterile medicinal products and biologicals.
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