New Approachs in Drug Quality Control: Matrices and Chemometrics
Sigrid Mennickent, M. de, B. Schulz, M. Vega, Claudia L Hernández G. Claudia L Hernández G. · InTech eBooks · 2012
All the analytical test procedures and manufacturing procedures are well documented and revision is undertaken as per specified protocol.Analytical methods are validated to give the reproducible results.Stability study as per stability protocol is considered to be very important area of Quality Assurance.Automated systems are becoming increasingly important tools for appropriate monitoring and controlling of the pharmaceutical packaging process.Solutions for comprehensive quality assurance or production data acquisition and evaluation are just as important as applications that meet the legislative requirements of different countries in terms of serial numbering and the unique marking of products.Quality control involves many phases, such as sample collection, measuring, analysis of results, and the approval/rejection of the batch.Nonetheless, the most important thing is the continuity and systematization of the quality control.Effective process validation contributes significantly to assuring drug quality.The basic principle of quality assurance is that a drug should be produced that is fit for its intended use.This principle incorporates the understanding that the following conditions exist: Quality, safety, and efficacy are designed or built into the product.Quality cannot be adequately assured merely by in-process and finished-product inspection or testing.Process validation is defined as the collection and evaluation of data, from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product.Process validation involves a series of activities taking place over the lifecycle of the product and process.Usually, process validation includes three stages:• Process Design: The commercial manufacturing process is defined during this stage based on knowledge gained through development and scale-up activities.• Process Qualification: During this stage, the process design is evaluated to determine if the process is capable of reproducible commercial manufacturing.• Process Verification: Ongoing assurance is gained during routine production that the process remains in a state of control [1-3]. New approaches in drug quality control Matrices Residue analysis of pharmaceuticals in the aquatic environmentResidue analysis of pharmaceuticals in the aquatic environment has attracted considerable interest during the last few years.