· Section II

3.4. Archive facilities should be provided for the secure storage and retrieval of study plans, raw data, final reports, samples of test items and specimens. Archive design and archive conditions should protect contents from untimely deterioration.

10.3 Only personnel authorised by management should have access to the archives. 

· 58.51

Space shall be provided for archives, limited to access by authorized personnel only, for the storage and retrieval of all raw data and specimens from completed studies.

· 58.190

(b) There shall be archives for orderly storage and expedient retrieval of all raw data, documentation, protocols, specimens, and interim and final reports. Conditions of storage shall minimize deterioration of the documents or specimens in accordance with the requirements for the time period of their retention and the nature of the documents or specimens. A testing facility may contract with commercial archives to provide a repository for all material to be retained. Raw data and specimens may be retained elsewhere provided that the archives have specific reference to those other locations.

· Section II 10.1

The following should be retained in the archives for the period specified by the appropriate authorities:

a) The study plan, raw data, samples of test and reference items, specimens, and the final report of each study;

· 58.190 Storage and retrieval of records and data

(a) All raw data, documentation, protocols, final reports, and specimens (except those specimens obtained from mutagenicity tests and wet specimens of blood, urine, feces, and biological fluids) generated as a result of a nonclinical laboratory study shall be retained.

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· Section II 10.1 

b) Records of all inspections performed by the Quality Assurance Programme, as well as master schedules;

c) Records of qualifications, training, experience and job descriptions of personnel;

d) Records and reports of the maintenance and calibration of apparatus;

e) Validation documentation for computerised systems;

f) The historical file of all Standard Operating Procedures;

g) Environmental monitoring records.

· 58.195

(d) The master schedule sheet, copies of protocols, and records of quality assurance inspections, as required by 58.35(c) shall be maintained by the quality assurance unit as an easily accessible system of records for the period of time specified in paragraphs (a) and (b) of this section.

(e) Summaries of training and experience and job descriptions required to be maintained by 58.29(b) may be retained along with all other testing facility employment records for the length of time specified in paragraphs (a) and (b) of this section.

(f) Records and reports of the maintenance and calibration and inspection of equipment, as required by 58.63(b) and (c), shall be retained for the length of time specified in paragraph (b) of this section.

· 58.81

(d) A historical file of standard operating procedures, and all revisions thereof, including the dates of such revisions, shall be maintained.

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· 58.195

(g) Records required by this part may be retained either as original records or as true copies such as photocopies, microfilm, microfiche, or other accurate reproductions of the original records.

· Section II

10.2 Material retained in the archives should be indexed so as to facilitate orderly storage and retrieval.

10.3 Only personnel authorised by management should have access to the archives. Movement of material in and out of the archives should be properly recorded. 

· 58.190

(c) An individual shall be identified as responsible for the archives. 

(d) Only authorized personnel shall enter the archives.

(e) Material retained or referred to in the archives shall be indexed to permit expedient retrieval. 

· Section II 10.1 

The following should be retained in the archives for the period specified by the appropriate authorities.

· 58.195

(a) Record retention requirements set forth in this section do not supersede the record retention requirements of any other regulations in this chapter. 

(b) Except as provided in paragraph (c) of this section, documentation records, raw data and specimens pertaining to a nonclinical laboratory study and required to be made by this part shall be retained in the archive(s) for whichever of the following periods is shortest: 

(1) A period of at least 2 years following the date on which an application for a research or marketing permit, in support of which the results of the nonclinical laboratory study were submitted, is approved by the Food and Drug Administration. This requirement does not apply to studies supporting investigational new drug applications (IND's) or applications for investigational device exemptions (IDE's), records of which shall be governed by the provisions of paragraph (b)(2) of this section. 

(2) A period of at least 5 years following the date on which the results of the nonclinical laboratory study are submitted to the Food and Drug Administration in support of an application for a research or marketing permit. 

(3) In other situations (e.g., where the nonclinical laboratory study does not result in the submission of the study in support of an application for a research or marketing permit), a period of at least 2 years following the date on which the study is completed, terminated, or discontinued.

· SectionII 10

In the absence of a required retention period, the final   disposition of any study materials should be documented.

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· Section II 10

When samples of test and reference items and specimens are   disposed of before the expiry of the required retention period for any   reason, this should be justified and documented. Samples of test and   reference items and specimens should be retained only as long as the quality   of the preparation permits evaluation.

· 58.195

(c) Wet specimens (except those specimens obtained from mutagenicity tests and wet specimens of blood, urine, feces, and biological fluids), samples of test or control articles, and specially prepared material, which are relatively fragile and differ markedly in stability and quality during storage, shall be retained only as long as the quality of the preparation affords evaluation. In no case shall retention be required for longer periods than those set forth in paragraphs (a) and (b) of this section.

· Section II 10.4

If a test facility or an archive contracting facility goes out of business and has no legal successor, the archive should be transferred to the archives of the sponsor(s) of the study(s).

· 58.195

(h) If a facility conducting nonclinical testing goes out of business, all raw data, documentation, and other material specified in this section shall be transferred to the archives of the sponsor of the study. The Food and Drug Administration shall be notified in writing of such a transfer.