Archiving and Retrieval of GMP Data and Other Documents

STANDARD OPERATING PROCEDUREPage 1 of 9
Document Number: S-162 Version 1.xx
Archiving and Retrieval of GMP Data and Other Documents

Standard Operating Procedure

Archiving and Retrieval of GMP Data and Other Documents

This is an example of a Standard Operating Procedure. It is a proposal and starting point only. The type and extent of documentation depends on the process environment. The proposed documentation should be adapted accordingly and should be based on individual risk assessments. There is no guarantee that this document will pass a regulatory inspection.

Publication from

Global on-line resource for validation and compliance

Copyright by Labcompliance. This document may only be saved and viewed or printed for personal use. Users may not transmit or duplicate this document in whole or in part, in any medium. Additional copies and licenses for department, site or corporate use can be ordered from

While every effort has been made to ensure the accuracy of information contained in this document, Labcompliance accepts no responsibility for errors or omissions. No liability can be accepted in any way.

Labcompliance offers books, master plans, complete Quality Packages with validation procedures, scripts and examples, SOPs, publications, training and presentation material, user club membership with more than 500 downloads and audio/web seminars. For more information and ordering, visit

1.PURPOSE

United States FDA and equivalent international GMP regulations require GMP study data and other documents to be archived. The facility must have an orderly system for storing such documents, and that system must provide an expedient method for retrieval of archived documents, for example, on the request of an inspector. This SOP describes steps to archive and retrieve documents generated or used during GMP operations.

2.SCOPE

Documents used during GMP operations. These may be records created during production and testing of a specific batch, such as tests results, environmental records and batch records, or documents that were available before such manufacturing and testing and are used during manufacturing and testing, such as SOPs.

3.GLOSSARY/DEFINITIONS

Note: For other definitions, see .

4.REFERENCE DOCUMENTS

4.1.SOP S-161: “Recording of GMP Raw Data”.
Order from

4.2.SOP S-315: “Retention and Archiving of Electronic Records”.
Order from

5.RESPONSIBILITIES

5.1.Archivist

5.1.1.Transfers the documents to the archive.

5.1.2.Creates and maintains an index for the archive.

5.1.3.Controls retrievals from the archive.

5.2.Quality Assurance

5.2.1.Assists in defining data and documents to be archived

5.2.2.Verifies compliance with internal procedure

5.3.Documentation department

5.3.1.Develops an identification, system, e.g., numbering system for records and other documents.

5.4.Operations manager or delegate

5.4.1.Requests identification code for single documents

5.4.2.Identify and submit records and other documents to the archivist

6.FREQUENCY OF USE

This SOP is used whenever documents used or created during manufacturing and testing are archived or retrieved from an archive.

7.PROCEDURE

7.1.Recording of GMP Data

GMP Data are recorded following the SOP in Ref. 4.1. Special care should be taken to:

• Record raw data on paper in durable blue or black ink.
• Correct errors using single-line error cross out. Each correction is dated, initialed and annotated.
• Apply 21 CFR 11 for electronic records and signatures.

1. Compiling and Organizing the GMP records and other documents
2. The operations manager or delegate requests identification codes for records and other documents.
3. The operations manager or delegate retains record files until the final batch is approved for release.
4. The operations manager or delegate organizes the files such that information is readily retrievable from within the file.
5. The operations manager or delegate forwards the study file to the archivist.
6. Transferring the files to the Archive
7. The archivist transfers the files to the archive.
8. The filesare archived by identification code.
9. Index of the Archive
10. The archivist develops and/or maintains an index of the archive. An example is shown in Attachment 8.1.
11. The index lists the files numerically by batch number.
12. Each entry lists the batch number, the date the file was archived and the title of the file.
13. For studies still in progress the index lists the location of the study.
14. On special request the archivist forwards the index to individual requesters.
15. Retrieval of Study Files
16. A request for retrieving documents from the archive is made to the archivist.
17. The archivist retrieves the file.
18. The archivist records the file number, the date and names and signatures of the archivist and borrower of the documentation in the check-in/out log in Attachment 8.2.
19. Borrowers don’t make changes to the file. This is confirmed by the borrower’s signature on the check-in log.
20. The archivist maintains the check-in/out log.
21. Retention Period

Any production, control, or distribution record that is required to be maintained in compliance with 21 CFR Part 211.180 and is specifically associated with a batch of a drug product shall be retained for at least 1 year after the expiration date of the batch or, in the case of certain OTC drug products lacking expiration dating because they meet the criteria for exemption under Sec. 211.137, 3 years after distribution of the batch.

Note: This retention period is applicable for the US FDA cGMP regulation. Other agencies may have different requirements.

7.7.Retention of Training Records

Summaries of training and experience and job descriptions are retained together with other testing facility employment records for the length of time specified in 7.6.

• Personnel responsible for the storage of such documents are aware of GMP retention requirements.
• The system ensures confidentiality of the personnel records at the time of external and internal inspections or audits.

1. Retention of Equipment Records

Equipment records and other testing facility employment records are retained for the length of time specified in 7.6.

• Personnel responsible for the storage of such documents are aware of GMP retention requirements.
• The GMP archive makes reference to the storage place of such records.

1. Retention of Electronic Records
2. Retention and archiving of electronic records follows the SOP in Ref. 4.2.
3. The archivist is responsible for managing electronic files and updating electronic formats when appropriate.
4. When updates are necessary, the archivist will state the type of change on the archive index.
5. Off-site Storage

If an off-site area is used to house documents the on-site archives contains specific reference to the material’s that are stored off-site and the location.

8.ATTACHMENTS

8.1.Index of an Archive

8.2.Check-in/out Log

The borrower confirms with his/her signature that the study file has not been changed.

(Replace with your company’s name) FOR INTERNAL USE