Control, Storage, Retention, Retrieval, and Disposal of Document(s).


Document shall be stored under lock and key in documentation room for the corresponding periods defined below (but not limited To):

LIST OF QUALITY RECORDS WITH RETENTION PERIODS

S.No.TitleLocation/Agency ResponsibleRetention Period
1.Record of Management RepresentativeManagement Representative3 Years
2.Records of Contract ReviewMarketingTill the customer is in contract
3.List of Approved vendorsPurchase/Management Representative3 Years (updates when ever a new vendor enters into contract)
4.Vendor Development RecordQuality AssuranceTill the vendor is in contract
5.Vendor Audit ReportsQuality Assurance3 Years
6.Approved sub contractors/Vendors performance recordPurchase/QA3 Years
7.Document Distribution/Issue RegisterManagement Representative3 Years
8.Master Formula & Packing  RecordFRD/PD/Quality assurancePermanent Record
9.Equipment logsProduction/Quality Assurance6 Years
10.Validation ReportsQuality AssurancePermanent Record
11.Batch Manufacturing RecordsProduction/Quality AssuranceOne year after expiry of the batch to which it relates or at least five years after certification of the batch by the Qualified person whichever is longer.  
12.Analytical reports for RM, PM and Finished ProductQuality Assurance/Quality Control6 Years
S.No.TitleLocation/Agency ResponsibleRetention Period
13.Stability ReportsQuality control/Quality AssurancePermanent
14.Store recordsQuality Assurance/Warehouse6 Years
15.Balance and Instrument Calibration recordsProduction, Quality Assurance, Quality Control, Maintenance6 Years
16.Technical data of inspection, measuring and test equipmentManagement Representative/Concerned DepartmentsPermanent
17.Internal  Audit ReportsManagement Representative3 Years  
18.Customer complaint RegisterMarketing/Quality Assurance3 Years
19.Record of preventive actionManagement RepresentativePermanent
20Training recordsAll DepartmentsTill the employee is in service +I year
21.Management ReviewManagement Representative3 years
22.Corrective and preventive action  Management Representative3 years
23.E.H.S RecordsManagement Representative5 Years
24.Standard Operating ProcedureAll DepartmentsExisting copy (ies) and one Obsolete copy shall be retained till further revision.
25.Personnel & Medical RecordsAll DepartmentsRetained till the person exists in the factory  
  • Except  where  legislations requires  longer  retention  periods, the complete  records

Pertaining to each batch, including original data such as laboratory work sheets   

    Should  be retained for at least one year after the expiry date of the batch or where there is no expiry date, for six years after the date of the manufacture.

  • Records of complaints should be retained up to the date of expiry + 1 year or I Year after the receipt of Complaint which ever is longer

    Master documents should be properly secured against theft, loss or alteration of information.

    A check should be made to ensure that all the necessary documents have been stored.

 Records should be protected from tampering or loss.

Records may also be retained by computer but the procedures and checks should be followed. Such records shall be progressively backed up using CD writer and the backed up data shall be kept at a location remote from the active file.

RETRIEVAL OF DOCUMENTS: 

 All documents shall be stored in the department in such a fashion that their retrieval is easy. The following system shall be adopted

A total list (may be alphabetical) of documents of all departments shall be made. The list shall contain the following details:

  • The name of the document.
  • Location of availability.
  • Person to be contacted for retrieval if available.
  • Record of documents issued if any for reference purpose and their subsequent retrieval shall be maintained in the register.

Completed batch processing and packaging records must always be kept under lock and key under the control of Q.A.

Retrieval of any important documents should be possible only on proper authorization of Q.A.

DISPOSAL OF DOCUMENTS:

The expired documents shall be destroyed by Q.A. with proper record and authorization by a suitable method such as shredding, burning etc.

Conclusion :

From the above information we have concluded the following points

Documents are very important for any industry and no document means you have not performed or executed the activities.

To maintain all the documents is not the responsibility of Quality Assurance

Every personnel working in pharmaceutical industry should check the documents for its current version.

Old documents shall be made obsolete before made effective of new documents

Documents shall be stored in lock and Key control along with access control and unauthorized entry to document cell shall be avoided and authorized personnel list shall be displayed outside the document cell.

If required individual racks shall be numbered and name of Documents which are available inside the rack shall be displayed and if required document cell tracking shall be maintained in Excel cell which should contains the location of documents.

In case of lack of space the documents shall be packed in shippers and shippers should be labelled from outside with details like Name of Documents, year and shipper number etc.

No old copies or obsolete copies of any documents shall be available in work place.

One thought on “Control, Storage, Retention, Retrieval, and Disposal of Document(s).

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