Packing Material Sampling SOP


1.0   PURPOSE:

1.1.  To establish a procedure for sampling of packing materials, which is truly a representative of the whole batch/lot, as per sampling plan.


2.1.      It is applicable to all types of packing materials (primary/secondary/tertiary) used for the packing of the product.

3.1.      Inventory Control manager
3.2.      Quality Assurance Manager
3.3.      QA Officer
3.4.      Store Worker

4.0    PROCEDURE:

1.1.   QAD receives the sampling/testing intimation (F-06-005) from Packing Material Store.
1.2.   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.
1.3.   Verify that the information being provided in sampling request is correct or not, according to the information has been given on request.
1.4.   Check that the materials received from approved vendor.
1.5.   Physical condition of the material will be checked for any damage, breakage or misprinting, etc.
1.6.   QA Officer & Store Worker wears mask and gloves before taking the sample.
1.7.   No. of samples to be taken per delivered packing material depends on the no of containers, follow  rule,(where n= No. of containers)
1.8.   QA officer will check/inspect as many as possible no. of units from different shippers/cartons.
1.9.   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
Sr. No.
MATERIALS
SAMPLE SIZE
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

1.10.  After sampling the container(s) are labeled with “SAMPLED”  sticker.
1.11.  QA Officer will enter all the sampling record in F-07-003.
1.12.  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.
1.13.  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.
1.14.  After release material is labeled with “RELEASED” slip (Green colored) and shifted to release area of Packing Material Store.
If rejected then material is labeled with “REJECTED” slip (Red colored) and shifted to rejected area of Packing Material Store.

5.0     REVIEW FREQUENCY:

SOP will be reviewed at least annually.



EVIDENCES OF RECORDS & REFERENCES
F-06-005 Request for Material Sampling
F-07-003 Packing Material Sampling Record
FORMAL KPIs (Key Performance Indicators)
Identification slips (Quarantine /Sampled/ Released/ Rejected) affixed on containers
GENERAL RISKS
CONTROL MEASURES

CUSTODIAN

Risks
Impact

No. of samples is not collected as per SOP
Testing will be compromised

Assure that sample size must be according to SOP



QA Officer

Identification label is not pasted on samples/ sampled containers
Mix-up of different materials/containers/ or of same material with different batch numbers

Affix the SAMPLED sticker as soon as the sample has been taken



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