Search results
Results from the WOW.Com Content Network
Process analytical technology (PAT) has been defined by the United States Food and Drug Administration (FDA) as a mechanism to design, analyze, and control pharmaceutical manufacturing processes through the measurement of critical process parameters (CPP) which affect the critical quality attributes (CQA).
More specifically, the ISPE's guide The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems in Pharmaceutical Manufacture describes a set of principles and procedures that help ensure that pharmaceutical products have the required quality. One of the core principles of GAMP is that quality cannot be tested ...
In the pharmaceutical industry, a wide range of excipients may be blended together with the active pharmaceutical ingredient to create the final blend used to manufacture the solid dosage form. The range of materials that may be blended (excipients, API), presents a number of variables which must be addressed to achieve target product quality ...
The material cost of a chemical process is the sum of the costs of all raw materials, intermediates, reagents, solvents, and catalysts procured from external vendors. Material costs may influence the selection of one synthetic route over another or the decision to outsource production of an intermediate.
Validation is a requirement of food, drug and pharmaceutical regulating agencies such as the US FDA and their good manufacturing practices guidelines. Since a wide variety of procedures, processes, and activities need to be validated, the field of validation is divided into a number of subsections including the following:
The ASME BPE is a voluntary consensus standard written by a team of over three hundred balanced subject matter experts. These individuals provide their knowledge and experience to drive technology and innovation forward safely and responsibly for the manufacturing of modern biopharmaceuticals.
TGA – Thermogravimetric analysis; TIKA – Transmitting ion kinetic analysis; TIMS – Thermal ionization mass spectrometry; TIRFM – Total internal reflection fluorescence microscopy; TLS – Photothermal lens spectroscopy, a type of photothermal spectroscopy; TMA – Thermomechanical analysis; TOF-MS – Time-of-flight mass spectrometry
A certified reference material is a particular form of measurement standard. Reference materials are particularly important for analytical chemistry and clinical analysis. [2] Since most analytical instrumentation is comparative, it requires a sample of known composition (reference material) for accurate calibration.