Retained Sample Quantity SOP


Retained Sample Quantity SOP


1.0   PURPOSE:

1.1.         To ensure retention of materials and finished product for future testing.

2.0    SCOPE:


2.1.         This procedure applies to all materials and finished products being used in___________Pharmaceuticals.

3.0   RESPONSIBILITY:


3.1.      QC Manager
3.2.      QA Officer
3.3.      QC Officer
3.4.      Lab. Attendant


4.0    PROCEDURE:


Description of the Retained Sample for different materials and finished goods is as under:
Sr. No.
Materials
Minimum Quantity
1.       
Raw Materials
1gm
2.       
Liquid Raw Materials
50ml
3.       
Unit Cartons
5 units
4.       
Capsule Shells
10
5.       
Pet Bottles
5
6.       
Labels
10
7.       
Leaflet
10
8.       
Printed Aluminum Foil
1ft
9.       
PVC Foil
6 Inches
10.   
Alu-Alu Foil
6 inches
11.   
Unit Boxes
1
12.   
Shippers/ Master Carton
1
13.   
Finished Products
Qty sufficient for 3 tests

5.0    REVIEW FREQUENCY:

SOP will be reviewed at least annually.





EVIDENCES OF RECORDS & REFERENCES
QA register of finished product retain samples
FORMAL KPIs (Key Performance Indicators)
Arrangement of sample according to Batch No.
GENERAL RISKS
CONTROL   MEASURES

CUSTODIAN

Risks
Impact

Sample is not retained as per specifications
Examination in future cannot be performed ,(if required)

Ensure retaining of each and every sample received

QA Officer



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