Saturday, November 20, 2010

Instructions for Self Life of Documents.

1.0         Purpose     :   To provide instructions for self life of documents.

2.0         Objective  :   To provide a documented procedure for self life of documents.

3.0           Scope      :    This procedure is applicable for self life of documents.

4.0         Responsibility   :
·        Primary: Officer – QA / Officer-Store
·        Secondary: Officer – QA Manager.


5.0      Procedure   :
Following is the list of documents and records and its shelf life:

Document
Shelf Life
Remarks

Specifications

Up to next revision
Obsolete copy will be preserved for period of minimum 2 years after cancellation
Master Batch manufacturing record
Up to next revision
Obsolete copy will be preserved for period of minimum 1 years after cancellation
Standard Operating procedure
Up to next revision
Obsolete copy will be preserved for period of minimum 1 years after cancellation



Validation Master Plan

Up to next revision
Obsolete copy will be preserved for period of minimum 1 years after cancellation
 Site master file    

Up to next revision
Obsolete copy will be preserved for period of minimum 1 years after cancellation
Validation protocol
Up to next revision
Obsolete copy will be preserved for period of minimum 1 years after cancellation
Quality system manual
Up to next revision
Obsolete copy will be preserved for period of minimum 1 years after cancellation


Document
Shelf Life
Remarks

Training records
At least 5 years
----
Distribution records
At least 5 years
----
Equipment maintenance records
Up to life of machine
----
Batch Manufacturing Record
Shelf life of product + 1year
Batch testing records
Shelf life of product + 1year
Product Complaint records
For life time





6.0      Reference Document :   Not applicable

7.0      Abbreviations :
·        QA   = Quality Assurance
·        SOP = Standard Operating Procedure
·        QC = Quality Control

8.0      Copies to Distribution Sites :
·        QA
·        QC 

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