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Raw Material Testing: When is Enough, Enough?

The CaSSS WCBP (Well-Characterized BioPharmaceutical) conference focusses on addressing issues at the interface of analytical development and global regulatory for biotechnology derived health intervention products. The goal of this symposium series is to provide a forum for discussing the latest challenges in biopharmaceutical development, as well as to consider practical approaches to address these challenges. Round Table discussions are a symposium format where a small group (12 to 15 participants) discuss industry practices, and regulatory experience with specific topics or issues. The Round Table discussion topic “Raw Material Testing, Enough is Enough, or Is It?”, took on the challenge of developing and managing a cGMP raw material testing program.

The group agreed that some form of stratification of raw materials was essential to establishing a manageable, effective testing program. Gone are the days of accepting raw materials based on Certificate of Analysis (CoA) and a compendial identity test. A full-on risk assessment for all the raw materials used in a biotech process is generally run by the Quality Control group with input from QA, Regulatory Affairs, and the relevant Process Development groups. There are no current guidance documents on how to do these risk assessments, but most companies evolve their processes over time as additional knowledge is gained across multiple programs. The first step is to define the categories for the materials based on the potential for the material to impact product CQAs and patient safety, followed by the more formal FMEA ranking of the individual materials.

The risk assessment is only the beginning, Quality Agreements and Vendor Qualification programs are two pillars of a successful raw material management effort. The utility of a solid Quality Agreement was highlighted by the group as a way of managing not only the raw material vendor, but also for sub-vendors. Notification of changes at a sub-vendor for a critical raw material should be relayed through the primary vendor so that the sponsor can ascertain whether the change will impact the raw material. Robust Vendor Qualification programs should be rigorous in order to assure CoA testing, and reduce redundant testing upon receipt. On-going verification of CoA results should be part of a vendor qualification program, along with periodic audits of systems and facilities.

Overall, the scope and complexity of raw material management has significantly evolved in response to better understanding of the impact of raw material changes to Quality Target Product Profiles (QTPPs) and patient safety. Raw materials risk assessments, robust Quality Agreements, and a comprehensive Vendor Qualification program are combined to manage complex raw material supply chains. Since the biopharmaceutical sponsor is responsible for all raw material testing, whether it is performed in-house or at a vendor or subcontractor; the criticality of developing solid systems cannot be over stated.


Blog article by: Joe Siemiatkoski