Records Maintenance in Quality Control Laboratory

The Quality Control laboratory should establish and maintain procedures for the identification, collection, indexing, retrieval, storage, maintenance and disposal of and access to all quality and technical/scientific records.All original observations, including calculations and derived data, calibration, validation and verification records and final results, should be retained on record for an appropriate period of time in accordance with national regulations and, if applicable, contractual arrangements, whichever is longer. The records should include the data recorded in the analytical worksheet by the technician or analyst

on consecutively numbered pages with references to the appendices containing the relevant recordings, e.g. chromatograms and spectra. The records for each test should contain sufficient information to permit the tests to be repeated and/or the results to be recalculated, if necessary. The records should include the identity of the personnel involved in the sampling, preparation and testing of the samples. The records of samples to be used in legal proceedings should be kept according to the legal requirements applicable to them.

 Note: The generally accepted retention period of shelf-life plus one year for a pharmaceutical product on the market and 15 years for an investigational product is recommended, unless national regulations are more stringent or contractual arrangements do not require otherwise.

4.3 All quality and technical/scientific records (including analytical test reports, certificates of analysis and analytical worksheets) should be legible, readily retrievable, stored and retained within facilities that provide a suitable environment that will prevent modification, damage or deterioration and/or loss. The conditions under which all original records are stored should be such as to ensure their security and confidentiality and access to them should be restricted to authorized personnel. Electronic storage and signatures may also be employed but with restricted access and in conformance with requirements for electronic records (12–16). 4.4 Quality management records should include reports from internal (and external if performed) audits and management reviews, as well as records of all complaints and their investigations, including records of possible corrective and preventive actions.

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