〈1665〉 Characterization and Qualification of Plastic Components and Systems Used
to Manufacture Pharmaceutical Drug Products and Biopharmaceutical Drug Substances
and
Products
A manufacturing process is the sum of the steps required to convert starting raw materials into a manufactured biopharmaceutical drug substance (DS) or a pharmaceutical or biopharmaceutical drug product (DP). Manufacturing processes are performed utilizing manufacturing systems which are the sum of the components that together comprise the equipment that converts starting raw materials into biopharmaceutical DSs or pharmaceutical or biopharmaceutical DPs.