Quality Management System for Active pharmaceutical

Quality Management System - integrating GMP into ISO- process steps and conditions, including permitted ranges and special precautionstogether with the actual process conditions used- the results of in-process tests- the yield obtained- a record of all deviations from the process instructions and all unusualoccurrencesThis list may not be considered as complete.9.1.4 Written instructions for the packaging operations involving the pure or finished APIshould be available and should detail:- specifications for the labels and for those packaging components that have directcontact with the API- a list of other packaging materials- any appropriate special precautions9.1.5 Written instructions for cleaning, calibration and maintenance of equipment shouldbe available.9.2 Prevention of product contamination9.2.1 Measures to avoid contamination should be designed into the manufacturingprocess, because the control of potential contaminants in the product itself isextremely difficult.9.2.2 Care should be taken to prevent contamination. This should be considered for allstages, but is essential after the final purification stage. Appropriate measuresinclude:- the use and location of equipment should be designed to minimise contamination- the avoidance of contamination due to the use of inadequately cleaned ormaintained equipment, corrosion or bearing leakage- the use of adequately purified solvents- the prevention of contamination by materials or utilities that have direct contactwith the pure or final API9.2.3 Special care needs to be taken during processing steps involving API such asisolation, drying and milling Such precautions should include:- isolation, drying, milling and homogenisation should be performed in closedsystems or controlled environments30