Raw material considerations.

Abstract

Raw materials (RM) testing and control strategy form a major part of the foundation of a well-characterized protein (WCP) or biopharmaceutical. Raw materials may be present in the final vial as excipients or may have product contact earlier in processing. Manufacturers of WCPs should use a scientific approach to set acceptance criteria and test methods for bulk raw materials which are not present in dosage forms in substantial amounts. These methods and standards should enable the procurement of specified RMs which enable the reliable preparation of a product which consistently meets its quality attributes. Manufacturers of WCPs must use available pharmacopoeial standards for excipients and bulk process RMs which cannot be substantially removed during purification or other processing steps. Manufacturers should support efforts to harmonize pharmacopoeial standards for excipients.