Retention Time of Product/Raw Material/other records SOP


1.0   PURPOSE:

1.1.            To ensure appropriate retention time of Product/Raw Material/other records in
________Pharmaceuticals.



2.1.      It is applied to QC Retained Samples of raw materials, packing material and finished products, also on BMRs and general records


3.1.      Q.A Manager
3.2.      Q.C Manager
3.3.      Production Manager
3.4.      Inventory Control Manager

4.0    PROCEDURE:

Sr. No.
Materials
Retention Time
Remarks
(if any)
1.1.    
Retained Sample of Finished Goods
1 year after expiry date
-----
1.2.    
Raw Materials Samples
1 year after expiry date
-----
1.3.    
Packing Materials Samples
3 years maximum
Retention time started from date of sampling
1.4.    
In-process Samples of products
1 year after expiry date of product
-----
1.5.    
Batch History Records
1 year after expiry date
-----
1.6.    
QC/QA/Production files and Records
5 years maximum
Retention time started from the date of last entry made in log/record
1.7.    
General Records
10 years maximum
Retention time started from the date of completion of respective record


5.0     REVIEW FREQUENCY:

SOP will be reviewed at least annually.


EVIDENCES OF RECORDS & REFERENCES
Destruction Note of Retained Sample/ Batch History
FORMAL KPIs
 (Key Performance Indicators)

Verification of the product/records as and when required
GENERAL RISKS
CONTROL MEASURES

CUSTODIAN
Risks
Impact


Product/Records disposed off before completion of retention time
There will be no evidence/record in place (if needed in future)
Before destruction make a rough list of the materials to be disposed off, and verify that all of them have completed their retention time
QA Officer/QA Manager


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