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The manufacture of biological active substances and medicinal products involves certain specific considerations dictated by the nature of these products and the processes used. The methods by which biological medicinal products are manufactured, controlled and administered require certain special precautions. Unlike conventional medicinal products, which are manufactured using physical and chemical techniques capable of a high degree of reproducibility, the manufacture of biological active substances and medicinal products involves biological processes and materials such as cell culture or extraction from living organisms. These biological processes may have inherent variability, so that the range and nature of by-products may vary. The principles of quality risk management (QRM) are therefore particularly important for this class of materials, and must be applied to develop a control strategy during all stages of manufacturing, so as to minimize variability and reduce the risk of contamination and cross-contamination.
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