chapter  10
26 Pages

Quality Control Systems

WithSarfaraz K. Niazi

Testing of therapeutic proteins follows similar methods and protocols as used for chemically derived or small molecule products; this includes the in-process testing as discussed under quality assurance issues. An example of required quality control (QC) tests would be given in a monograph such as the one included for interferon and erythropoietin in the European Pharmacopoeia (EP) or British Pharmacopoeia (BP). This would be release testing; testing is also a part of a comprehensive QC program that monitors various parameters and responses, definition of critical parameters, in-process control of intermediary compounds, and tests of drug substance and drug product. In its usual description, the quality control comprises in-process control, control of drug substance/product, and a description of analytical methods used to characterize intermediary and final products.