To lay down procedure for sampling of the packaging material in order to get a representative Sample of the whole lot for analysis.
This procedure is applicable for various packaging materials received.
3.1 Doing : Technical Assistant
3.2 Checking : Executive/ Manager
Head of the Department
5.1 On receipt of the packaging verification report with sign of Store Incharge from the Packaging material store, make entry In the Sampling register for following details.
a) Batch. No.
b) Date of receipt e) Quantity received
c) Name of P.M. f) Challan no & date
d) Supplier/Manufacturing name
5.2 While entering details of Physical Verification Report of all packaging material into sampling register check that name of Manufacturer is part of Approved vendor list.
In case the material is coming for first time send the samples for qualification or trials to packing department.
5.3 If the Material is not from an approved vendor then material is not to be sampled & intimate the Quality Head.
5.4 Assign the work of sampling of the material to the Q.C. Chemist. List of authorised person should be attached.
5.5 Check the details given on physical Verification Report with the Manufacturer label on the packaging material boxes /rolls and the label affixed by the Stores on all 100 % containers.
5.6 Use sampling devices like scissors, Cutter, Knives for sampling.
5.7 Do the sampling as per √n+1 or 5, whichever is more to open the number of boxes/rolls. Take the samples from loose box & from the container/boxes identified or received in damaged condition.
5.7.1 If any boxes/ rolls found in damaged condition intimate the Packaging material Store Incharge and QC Executive/Manager for part Qty. Rejection & part Qty. Approved.
5.8 Carry out the sampling of all P.M. as per following sampling plan for VISUAL EXAMINATION from each selected boxes of all packaging material.
5.8.1 No. OF BOX RECEIVED SAMPLE SIZE
Up to 150 20
151 to 280 32
281 to 500 50
501 to 1200 90
1201 to 3200 125
3201 to 10000 200
10001 to 35000 315
35001 to 150000 500
150001 to 500000 800
500001 to above 1250
5.9 Examine the samples visually during sampling as per attached check list
5.10 Carry out the sampling as per the list prepared for destructive tests. Destroy the remaining samples after completion of analysis & document the same.
5.11 Carry out the sampling of plain & printed aluminium foil, PVC & PVDC film in LAF bench
5.12 Provided in A/C area as per S.O.P.
5.13 Close all the boxes/ Rolls/ Bundles properly with BOPP tap after sampling, mark the “SAMPLED” stamp on all sampled boxes/rolls/Bundles.
5.14 After completion of sampling, Release the Material for Testing in SAP.
5.15 Enter the Following details in computer for “UNDER TEST” label.
Batch No :
Plant Id :
Sampled by :
Sampled Qty :
Sampled Date :
5.16 Affix Yellow coloured “UNDERTEST” label Duly Filled & Signed, at least one label for each pellet of P.M. Consignment.
5.17 Take the sample to the P.M.Q.C. department for further testing as per specification.
QC = Quality Control
P.V.C = Poly vinyl chloride
P.V.D.C = Polyvinyl dine Chloride
No. = Number
Dept. = Department
& = And
PMQC = Packaging Material Quality Control
n = Number of boxes
P.M. = Packaging Material
Qty = Quantity
A.R.No. = Analytical Report Number
BOPP = Biaxually Oriented Poly Propylene
Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of Pharmaceutical Guidelines, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
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