by The in-vitro diagnostics (IVD) industry plays a critical role in healthcare by providing tests and tools to detect, diagnose, monitor, and manage diseases. As the complexity and sophistication of IVD tests have increased over the years, so too have the demands on the quality and reliability of raw materials that go into manufacturing these products. Ensuring only the highest quality raw materials is essential to maintaining patient safety and delivering accurate diagnostic results.
Raw Material Sourcing and Supplier Qualification
Raw material quality starts at the source. IVD manufacturers must qualified suppliers and implement stringent sourcing processes to verify material quality from the very beginning. This involves qualifying new suppliers through audits of their quality management systems, manufacturing facilities, analytical testing capabilities and more. Only suppliers meeting strict qualification criteria are approved to supply raw materials.
Manufacturers also maintain approved supplier lists and carefully vet any changes to raw material sources. Regular audits and inspections are conducted to ensure continuing conformance to quality standards. Tight control of the supply chain from raw material producer to the IVD manufacturer’s receiving dock is necessary to avoid potential quality issues.
Characterization and Testing of Incoming Materials
Upon receipt at the manufacturing site, each raw material batch undergoes thorough characterization and testing before being released for production. This includes reviewing accompanying documentation for things like certificates of analysis, transportation records, and compliance with ordering specifications.
Visual inspections are carried out to check for deficiencies, damage or inconsistent appearance. Chemical, physical and functional analyses are then performed to verify identity, purity, composition and other critical quality attributes as defined in the material specification.
Microbiological testing may also be included to exclude contamination risks. Only raw material batches that pass all release testing are cleared for use in manufacturing IVD products. Any failing batches are promptly rejected and not used.
Storage and Distribution of Raw Materials
Proper storage and distribution of qualified raw materials is another crucial aspect of quality control. Most raw materials used in IVD manufacturing are temperature and humidity sensitive. Specific storage conditions defined in material specifications must be carefully followed.
State-of-the-art warehouse management systems with temperature and humidity monitoring are used. First-expired-first-out (FEFO) practices ensure oldest stock is used first. Strict inventory controls and traceability allow full trace back to the shipping container level in case of any later quality issues.
Robust quality systems also govern the distribution of raw materials within manufacturing sites. Materials are transported in clean, controlled environments to avoid contamination or improper storage conditions during transit between warehouses and production areas.
Raw Material Requalification Program
Raw material quality must be assured for the full shelf life and lifetime of the IVD products made from them. IVD manufacturers therefore implement comprehensive raw material requalification programs. Periodic stability testing ensures critical attributes remain consistent over time in long term storage and the materials continue to perform as expected in manufacturing.
Any changes in characteristics that could impact product quality trigger an investigation. Material nearing expiry undergoes retests to assess extension of the expiry date or confirmation of the stated shelf life. This ongoing monitoring helps proactively identify and address potential quality issues to ensure IVD tests perform reliably throughout their usage period.
Ensuring Patient Safety
The quality of raw materials is foundational to producing accurate and reliable IVD tests. Even the slightest change in a critical reagent or component could potentially compromise test results and impact patient care. By implementing robust quality systems and controls from supplier qualification to final product release, IVD manufacturers assume responsibility for patient safety. Only through diligent oversight of every link in the supply chain can high quality diagnostics be delivered consistently to clinics and laboratories worldwide.
