Standard Operating Procedure of Packing Material Sampling in Pharmaceuticals is describe in this post.
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1.0 Purpose:
To establish a procedure for sampling of packing materials, which is truly a representative of the whole batch/lot, as per sampling plan.
2.0 Scope:
2.1 It is applicable to all types of packing materials (primary/secondary/tertiary) used for the packing of the product.
3.0 Responsibilities:
3.1 Inventory Control manager
3.2 Quality Assurance Manager
3.3 QA Officer
3.4 Store Worker
4.0 Procedure:
4.1 QAD receives the sampling/testing intimation (F-06-005) from Packing Material Store.
4.2 QA officer in the presence of Store Pharmacist checks the container(s) that it has been placed properly in Quarantine and an identification card “QUARANTINE” is pasted on each container.
4.3 Verify that the information being provided in sampling request is correct or not, according to the information has been given on request.
4.4 Check that the materials received from approved vendor.
4.5 Physical condition of the material will be checked for any damage, breakage or misprinting, etc.
4.6 QA Officer & Store Worker wears mask and gloves before taking the sample.
4.7 No. of samples to be taken per delivered packing material depends on the no of containers, follow √n+1 rule,(where n= No. of containers)
4.8 QA officer will check/inspect as many as possible no. of units from different shippers/cartons.
4.9 Minimum number of total units to be collected is as follows:
|
Sr.
No. |
MATERIALS |
SAMPLE
SIZE |
|
1. |
Unit Cartons |
NLT 10 |
|
2. |
Pet Bottles |
NLT 10 |
|
3. |
Caps |
NLT 10 |
|
4. |
Leaflet |
NLT 5 |
|
5. |
Label |
NLT 5 |
|
6. |
Printed Aluminum Foil |
NLT 2ft |
|
7. |
PVC Foil |
NLT 1ft |
|
8. |
Alu-Alu Foil |
NLT 1 ft |
|
9. |
Unit Boxes |
NLT 5 |
|
10. |
Shippers/Master Carton |
NLT 2 |
4.10. After sampling the container(s) are labeled with “SAMPLED” sticker.
4.11. QA Officer will enter all the sampling record in F-07-003.
4.12. Sample is then packed into a polybag with an identification “SAMPLE” label affixed outside the bag and handed over to the QC analyst for testing.
4.13. Sample is tested and then Quality Control Manger will decide about the release/conditionally release/ sorting or rejection of the material with respect to testing results.
4.14. After release material is labeled with “RELEASED” slip (Green colored) and shifted to release area of Packing Material Store.
4.15. If rejected then material is labeled with “REJECTED” slip (Red colored) and shifted to rejected area of Packing Material Store.
Note: Printed Aluminum foil must be sampled in the sampling room under sampling Hood.
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