SOP on Storage and Retrieval of Records & Data

SOP on Storage and Retrieval of Records & Data

1.0 Purpose: This SOP describes the requirements for storage and retrieval of records and data related to drug manufacture.

2.0 Scope: This SOP applies to Production Staff and Quality Control Staff.

3.0 Responsibility: Production Chemist to ensure that procedure is followed.

4.0 Materials and Equipment: As required

5.0 Procedure:

5.01 A dedicated space for storage of raw data, documentation, protocols and interim & final reports has been provided.

5.02 All records and data are stored in orderly manner and a system is maintained for expedient retrieval of archived materials.

5.03 Storage conditions (e.g. temperature, humidity etc.) are related to nature of stored documents. Storage conditions which foster accelerated deterioration are avoided. Storage conditions are monitored so that deviations from proper storage conditions can be promptly rectified.

5.04 The on-site archives contain specific references to materials that are stored off-site and location of alternate storage site(s).

5.05 The office staff is responsible for archives.

5.06 Only authorized personnel (i.e. office staff, production manager, quality assurance manager) are allowed to enter the archives. When materials are removed from archives for any reason, a record is maintained for what is removed and by whom. Follow up is provided by archive personnel to ensure propmpt return of materials to archives.

5.07 Materials retained or referred to in archives are indexed to permit expedient retrieval.

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