SOP on Laboratory Records

SOP on Laboratory Records
1.0 Purpose: This SOP describes the information’s to be recorded in laboratory record of analysis or test certificates.
2.0 Scope: This SOP applies to Quality Control laboratory.
3.0 Responsibility: Quality Control Manager to ensure that the procedure is followed.
4.0 Materials and Equipment: As required.
5.0 Procedure: 
5.1.0 Laboratory records includes complete data derived from all tests necessary to assure compliance with established specifications and standards, including examinations and assays, as follows – 
5.1.1 A description of the sample received for testing, quantity, lot number or other distinctive code, and date sample was received for testing.
5.1.2 A statement of each method used in the testing of the sample.
5.1.3 A statement of the weight or measure of sample used for each test where appropriate.
5.1.4 A complete record of all data secured in the course of each test, including all graphs, charts, and spectra from laboratory instrumentation properly identified to show the specific component, drug product container, closure, in-process material, or drug product, and lot tested.
5.1.5 A record of all calculations performed in connection with the test, including units of measure, conversion factors, and equivalency factors.
5.1.6 A statement of the results of tests and how the results compare with established standards of identity, strength, quality, and purity for the component, drug product container, closure, in-process material or drug product tested.
5.1.7 The initials or signature of the person who performs each test and the date(s) the tests were performed.
5.1.8 The initials or signature of a second person showing that the original records have been reviewed for accuracy, completeness, and compliance with established standards.
5.2.0 Complete records are maintained of any modification of an established method employed in testing. Such records includes the reason for the modification and data to verify that the modification  produced results that are at least as accurate and reliable for the material being tested as the established method.
5.3.0 Complete records are maintained of any testing and standardization of laboratory reference standards, reagents, and standard solutions.
5.4.0 Complete records are maintained of the periodic calibration of laboratory instruments, apparatus, and recording devices.
5.5.0 Complete records are maintained of all stability testing performed.   

Leave a Comment