In-Process Control Methods for the Manufacture of APIs
October 1st 2005In-process methods are key components of quality control in a chemical manufacturing plant. These methods ensure that a production reaction step conducted by trained operators within the entire validated process will produce a quality chemical entity in the expected yields. The presence of impurities and related compounds (derived from the reaction or secondary reactions) is a critical parameter that determines a synthetic material's quality.
Organic Impurities in Chemical Drug Substances
October 1st 2005Chemical purity is the most important quality characteristic of a pharmaceutical substance. This article describes the latest scientific and technological advances to meet recent pharmacopoeial and regulatory requirements regarding the control of organic impurities in synthetically produced active substances. Future developments and suggestions for those working in quality control and raw material selection are discussed.
Pharmaceutical Dust Extraction and Vacuum Cleaning
October 1st 2005Dust extraction and centralized vacuum cleaning systems vary in their design, performance and costs. Different companies have different approaches to their design, however, there are some basic rules that must be followed if these systems are going to be immediately effective and avoid future problems.