Laboratory control records
Article 27
1. Laboratory control records shall be prepared for each active substance. Those laboratory control records shall include complete data derived from all tests conducted to ensure compliance with established specifications and standards, including examinations and assays and in particular, the following aspects: (a) a description of samples received for testing, including the material name or source, batch number or other distinctive code, date of sampling, and, where appropriate, the quantity and date the sample was received for testing; (b) a description of or reference to each test method used; (c) a statement of the weight or measure of the sample used for each test as described by the method; data on or cross-reference to the preparation and testing of reference standards, reagents and standard solutions; (d) a complete record of all raw data generated during each test, in addition to graphs, charts, and spectra from laboratory instrumentation, properly identified to show the specific material and batch tested; (e) a record of all calculations performed in connection with the test, including, for example, units of measure, conversion factors, and equivalency factors; (f) a statement of the test results and how they compare with established acceptance criteria; (g) the signature of the person who performed each test and the dates when the tests were performed; (h) the date and signature of a second person showing that the original records have been reviewed for accuracy, completeness, and compliance with established standards. 2. Laboratory control records shall also include complete records on: (a) all modifications to an established analytical method; (b) periodic calibration of laboratory instruments, apparatus, gauges, and recording devices; (c) all stability testing performed on active substances; (d) out-of-specification investigations.