Positive Material Identification/Raw Material Screening

Positive Material Identification and Raw Material Screening in QA/QC

Raw material identification (RMI) and raw material screening (RMS) are regulatory requirements for pharmaceutical drug manufacturers. That is because one of the first steps in the manufacturing of any pharmaceutical product is the identification and validation of various incoming raw materials. Impurities and adulterants in starting materials pose potential health threats when present in the manufacturing of pharmaceutical APIs and drug products. These same impurities and adulterants may also result in lower production yields and greater needs for product purification.

Positive material identification (PMI) can prevent potential drug product failure during manufacturing, and is used for component validation in QA/QC. It is a non-destructive test method used for determining material composition and most frequently uses X-ray fluorescence (XRF).

Several technologies can identify and quantify raw materials. FT-NIR spectroscopy via fibre optic probes is rapidly becoming a standard method of accomplishing this crucial material validation, providing speed, efficiency and flexibility for identification of both solid materials and liquids in drug manufacturing.

Raman spectroscopy provides high selective information content and eliminates the need of sample preparation. This, combined with the capability to probe materials directly through transparent packaging material makes Raman spectroscopy a key method of choice for RMI.

Nuclear Magnetic Resonance (NMR) is a qualitative, structurally definitive technique that can confirm or deny molecular configuration(s). If adulterants, impurities or unknown materials are present, NMR spectral peaks are used to determine acceptability and NMR offers fully automated RMS for qualitative and quantitative RMI.