Stories of foreign particulate matter (FPM) found in medication and food products often occur in the news. FPM doesn’t just influence the effectiveness of a product; it can lead to product recall and regulatory action from government entities. Investigating the cause can be expensive, but a carefully designed Quality by Design (QbD) particulate program can help save a manufacturer money and time by providing cost-effective, efficient, and conclusive data. “Forensics in QbD: Addressing Foreign Particulate Matter Investigations” was written by Karen Smith and Julianne Wolfe, both particulate experts for RJ Lee Group. The article was published in American Pharmaceutical Review and explains strategies for FPM investigations.
Building a Successful Particulate Program
A flexible, versatile particulate program actually grows with the needs of an organization, providing a conclusive answer to the FPM investigation’s questions. The components of a successful program will vary from organization to organization, but most will have several processes in common.
First, regulated product inspections detect the presence of FPM, which is then removed from the process. Particle-free water is used to rinse the FPM clean of matrix material. Due to the size of the material, which can be as small as 20 μm, a stereomicroscope is used to isolate the material. Next, an analyst will categorize or classify the particle based on its attributes, which can include morphology, luster, transparency, color, quantity, mobility, and buoyancy.
Once the FPM’s attributes are determined, an analytical regimen is used to identify the material. These materials are then traced back through the process to find their source and minimize the risk of future contamination occurrences. If the problem reoccurs, the knowledge base established by the FPM investigation will make the identification and elimination of future issues faster and less expensive.
Particulate program requirements include comprehensiveness, flexibility, versatility, and conclusiveness, but cost effectiveness is an undeniable factor. The article also contains four case studies, one for a company that had no particulate program in place, two with partial particulate programs, and one with a full particulate program. These demonstrate the time and cost associated with the FPM investigations at each level. Using a tiered approach that takes advantage of the program’s flexibility, the organization can make decisions on whether it should proceed with the FPM characterization using a risk-based approach.
To read “Forensics in QbD: Addressing Foreign Particulate Matter Investigations,” please click here for the American Pharmaceutical Review’s September issue.