“Compliance Methods” is a reoccuring column in the Journal of GXP Compliance that discusses approaches, analytical methods, and techniques useful to practitioners in compliance and validation. “Compliance Methods” presents less common approaches or novel uses of well-known techniques. The purpose of this column is to provide information applicable to problem-solving situations, investigations, root cause analysis, and other applications.
The first column discusses various types of vibrational spectroscopy, including near infrared (NIR) spectroscopy, mid-IR (MIR), and Raman spectroscopy. These methods are useful in various compliance and investigative applications.
This second installment of “Compliance Methods” addresses how midinfrared (MIR) spectroscopy can be used for a variety of established GMP compliance activities, such as identification of pharmaceutical raw materials and packaging, identification of suspect counterfeit samples, chemical structural confirmation, identification of active pharmaceutical ingredients in drug products, and identification of extraneous or particulate matter. MIR spectroscopy can also identify chemical compositions of liquid and solid mixtures. A description of sample preparation techniques and the differences therein between the United States Pharmacopeia, European Pharmacopeia, and Japanese Pharmacopeia methods are also discussed.
The third installment discusses optical microscopy. Optical microscopy is often a good first step for characterizing pharmaceutical raw materials, investigating production problems, and identifying extraneous matter. Optical microscopy is a well-accepted technique in all sciences, and with training, a wealth of information can be obtained from the microscope. A description of the basic types of optical microscopes, information that can be obtained from optical microscopes, and their applications in pharmaceutical compliance applications are discussed.
The fourth installment discusses how ecanning electron microscopy (SEMs) and energy dispersive x-ray spectroscopy (EDS) can provide useful information about the microstructure of pharmaceutical powders and oral dosage formulations, including particle sizing, active pharmaceutical ingredients (API) characterization, and identification of extraneous matter from production, development, or customer complaints.