STANDARD TEST PROCEDURES (STPs) & LABORATORY RECORDS

Laboratory records should include the complete data derived from tests necessary to assure compliance with established specifications and standards including examination and assays.

v  A description of the sample received for testing with identification of source (that is, location from where samples was obtained), quality, lot number and date sample was received for testing. Where samples are
taken from a representative number of containers, it is necessary to cross reference the sample the samples to the containers from which they are taken. The amount of sample needs to recorded to allow effective reconciliation.

v  A statement of each method used in the testing of the sample. Test method may be modified with time and it is important that the retained records clearly indicate which methodology was actually used. This is usually done by indicating the monograph reference number and issue date. Obviously copies of monographs which rebate the retained records must be retained.

v  A complete record of all data collected in the coarse of testing should be provided, including all graphs, charts and spectra from laboratory instrumentation properly identified to show the specific component drug product containers, closure in-process material or drug product and lot tested. A record of all calculations performed in connection with the tests including units of measures, conversion factors, and equivalency factors should be appended.

v  A statement of the results and how they compare with established standards of identity, strength, quality for the component, drug product container, closure, in-process material or drug product tested.

v  Records must indicate who performed each test. Since the initials and signature of many people are indecipherable, it is recommended that printed or typed names should also be shown.

Complete records shall be maintained of any modification of an established method employed in testing. Such records shall include the reason for modification and data should verify that modification.

Complete records should be maintained of any standardization of laboratory working standards, reagents and their solutions. Records should also be maintained of the periodic calibration of laboratory instruments, apparatus, gauges and recording devices and all stability testing performed as per requirement.