A program for control of biopharmaceutical raw materials is a critical quality system that helps assure patient safety and contributes to product quality. The systems for testing and acceptance must be scientifically based, and meet global regulatory requirements and standards. When a new raw material is sourced, it is important to quickly establish the quality profiles for the supplier and the raw material. Among the numerous challenges that confront a company attempting to establish an effective, compliant, raw materials program, this paper will address the following: • Challenges in sourcing and tracing raw materials that are suitable for use in human therapeutics • Challenges and obstacles in qualifying suppliers • Special challenges faced by a firm that has outsourced its manufacturing and/or quality control (QC) testing…
Tag: <span>supplier qualification</span>
Regulations and common sense require that a manufacturer qualify both the raw materials and the suppliers the firm will use to produce GMP supplies of a pharmaceutical or biopharmaceutical. Because the firm is accepting legal liability for the quality of all raw materials, it makes good business sense to devote resources to these activities. This article explores how to assure that qualification is complete, efficient, and compliant with current good manufacturing practice (cGMP), and discusses the challenges faced by today’s manufacturers…