| Archives establishment and management have played a very important role in non-clinical drug safety evaluation and
any scientific research programe. Through literature review, we found that there is few literature review about GLP institutions archives
management, when it comes to the systematic and comprehensive comparison on the establishment and management between GLP
archives and scientific research archives, the relevant article is zero. This article comprehensively reviews relevant provisions and
experience of archive management from 3 aspects of hardware facilities, archive practices and the problems we should pay attention to.
Based on "Scientific and Technological Research Rrecords Management Interim Provisions" released by State Archives Administration,
we compared the GLP archive practices and scientific research archive practices. Combined with author's seven years GLP archives
management experience as well as multiple GLP certification on-site inspection of State Food and Drug Administration (SFDA) ,
summarized the similarities and differences between the two of them in the aspects of objectives, facilities, temperature and humidity
requirements, file protection, setting up SOPs, archives management personnel qualification, responsibilities of the staff, archiving range,
archiving form, receiving and reviewing data file, archiving time, retention period, borrowing and returning provisions, file writing
normative, in and out record, preservation of electronic documents, further more, highlighted the characteristic and emphasis of GLP
archives. Through this in-depth comprehensive comparative analysis, we arrival at a conclusion that the GLP archives management is
more explicit, specific, detailed and operable. In order to narrow the gap between the developed countries and the international, to
conform to the GLP development needs of the new era, we should discuss with colleagues how to further perfect the GLP archives
management, to ensure the accuracy, clarity, reliability and traceability of the documents, and to improve the GLP organization's overall
management level. |
