Standard Operating Procedure of Retain Sample Quantity for Future Examination is describe in this post.
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1. Purpose:
1.1. To ensure retention of materials and finished product for future testing.
2. Scope:
2.1. This procedure applies to all materials and finished products being used in Pharmaceuticals.
3. Responsibilities:
3.1. QC Manager
3.2. QA Officer
3.3. QC Officer
3.4. Lab. Attendant
4. Procedure:
Description of the Retained Sample for different materials and finished goods is as under:
Sr. # |
Materials |
Minimum Quantity |
1. |
Raw Materials |
1gm |
2. |
Liquid Raw Materials |
50ml |
3. |
Unit Cartons |
5 units |
4. |
Glass Ampoule |
10 |
5. |
Glass Vials |
3 |
6. |
Rubber Stoppers |
5 |
7. |
Capsule Shells |
10 |
8. |
Seals for rubber stopper |
5 |
9. |
Pet Bottles |
5 |
10. |
Hangers |
5 |
11. |
Applicator |
4 |
12. |
Labels |
10 |
13. |
Leaflet |
10 |
14. |
Printed Aluminum Foil |
1ft |
15. |
PVC Foil |
6 Inches |
16. |
Alu-Alu Foil |
6 inches |
17. |
Unit Boxes |
1 |
18. |
Shippers/ Master Carton |
1 |
19. |
Ampoules Net |
5 |
20. |
Finished Products |
Qty sufficient for 3 tests |
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