A Review of Process Analytical Technology (PAT) in the U.S.Pharmaceutical Industry

Detecting active ingredients of insect repellents and sunscreens topically in skin by Raman spectroscopy

“…Raman spectroscopy provides qualitative information regarding the composition of the sample under analysis as well as quantitative information related to the presence of the compound, which can be useful to manufacturers to detect and quantify the active ingredients of pharmaceutical formulations topically applied to the skin and may be used for quality control during the production process, thus attending GMP and PAT technology processes. [17][18][19] As the manufacturers know the concentration of the active ingredients and excipients of the formulation, it is possible to observe the presence of each active ingredient in the skin of an individual following an application protocol, or even to perform tests for degradation due to environmental conditions or simulated situations of use.…”

“…Currently, manufacturers of pharmaceutical products employ good manufacturing practices (GMPs) and process analytical technologies (PATs) to perform quality control during the production process. [17][18][19] Optical techniques such as near-infrared and Raman spectroscopy have been proposed as methods to obtain chemical information for real-time process monitoring and control for PAT technology as they supply the data from which relevant process and product information and conclusions are to be extracted. 20 Also, Raman spectroscopy has been used to detect the presence and bioavailability of pharmaceutical and natural active products applied topically onto the skin, 21,22 which may turn into a technique of choice for rapid identification and quantification of such products in vivo without sample preparation.…”

Quality by Design: An Overview of the Basic Concepts

“…PAT entails analysis of product quality attributes during the various stages of the manufacturing process of a biomolecule. The analysis is often conducted online using either probes inserted into the bioreactor to monitor critical components such as the cell density or sterile sampling devices to divert the stream from a purification column to assess the product purity [7]. In either case, the online analysis enables operators on the manufacturing floor to make real-time adjustments to the process parameters so as to obtain the desired product profile at every stage of the manufacturing process.…”

Transmission Near-Infrared (NIR) and Photon Time-of-Flight (PTOF) Spectroscopy in a Comparative Analysis of Pharmaceuticals

“…Process analytical technology has been defined by the United States Food and Drug Administration as a mechanism to design, analyze, and control pharmaceutical manufacturing processes. 1 Nearinfrared spectroscopy (NIRS) is a powerful spectroscopic technique widely employed in the pharmaceutical industry to monitor different stages of the production process and to analyze the final products. [2][3][4][5] Since its successful online implementation by major pharmaceutical companies, NIRS has been widely used in critical stages of the pharmaceutical process for the characterization of raw materials, drying, blending, and tableting.…”