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.	Title	Location/Agency Responsible	Retention Period
1.	Record of Management Representative	Management Representative	3 Years
2.	Records of Contract Review	Marketing	Till the customer is in contract
3.	List of Approved vendors	Purchase/Management Representative	3 Years (updates when ever a new vendor enters into contract)
4.	Vendor Development Record	Quality Assurance	Till the vendor is in contract
5.	Vendor Audit Reports	Quality Assurance	3 Years
6.	Approved sub contractors/Vendors performance record	Purchase/QA	3 Years
7.	Document Distribution/Issue Register	Management Representative	3 Years
8.	Master Formula & Packing  Record	FRD/PD/Quality assurance	Permanent Record
9.	Equipment logs	Production/Quality Assurance	6 Years
10.	Validation Reports	Quality Assurance	Permanent Record
11.	Batch Manufacturing Records	Production/Quality Assurance	One 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 Product	Quality Assurance/Quality Control	6 Years

S.No.	Title	Location/Agency Responsible	Retention Period
13.	Stability Reports	Quality control/Quality Assurance	Permanent
14.	Store records	Quality Assurance/Warehouse	6 Years
15.	Balance and Instrument Calibration records	Production, Quality Assurance, Quality Control, Maintenance	6 Years
16.	Technical data of inspection, measuring and test equipment	Management Representative/Concerned Departments	Permanent
17.	Internal  Audit Reports	Management Representative	3 Years
18.	Customer complaint Register	Marketing/Quality Assurance	3 Years
19.	Record of preventive action	Management Representative	Permanent
20	Training records	All Departments	Till the employee is in service +I year
21.	Management Review	Management Representative	3 years
22.	Corrective and preventive action	Management Representative	3 years
23.	E.H.S Records	Management Representative	5 Years
24.	Standard Operating Procedure	All Departments	Existing copy (ies) and one Obsolete copy shall be retained till further revision.
25.	Personnel & Medical Records	All Departments	Retained 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.

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