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