Quality Management System for Active pharmaceutical

Quality Management System - integrating GMP into ISO10.5 Inspection and test records10.5.1 Records should be established and maintained that demonstrate that each batch ofproduct has been inspected and tested according to the pre-defined criteria. Therecords should clearly show whether the batch passed or failed the inspections andtests. In cases where a batch fails there should be established procedures forcontrolling non-conforming product and these should be applied as outlined inchapter 13.10.5.2 Records of tests should include:- the name and batch number of the material being tested- a reference to the relevant specification and the test procedure being used- an identification of the standard, if used- results of all weighings, measurements and readings taken- all observations and calculations and the results obtained therefrom, which shouldbe dated and signed by the person conducting the test- analytical equipment identificationThese records should be checked for accuracy independently. Quality criticalrecords should be countersigned where they contain manual calculations. Inspectionand test records should be retained for a specified period of time, (see chapter 16).10.6 Retained samples10.6.1 Relevant samples should be retained for a prescribed period and under definedconditions, so that investigation of quality status may be performed, if necessary, at alater date. As retained samples are a form of quality record, the reader is alsoreferred to chapter 16.10.6.2 Samples should be stored in a container (the same as, or equivalent to, that used forbulk storage or market packaging) and under conditions (consistent with the productlabel) which prevent loss, damage or deterioration.10.6.3 Samples should be retained in quantities sufficient to allow at least two full analysesto be performed.10.6.4 Samples of raw material and intermediate should be retained for at least 12 monthsfollowing release of the batch(es) of API to which they relate.36