SAMPLING OF PACKING MATERIALS

OBJECTIVE

To lay down a procedure for sampling of packaging materials.

SCOPE

To describe the procedure for sampling of Primary packing materials i.e. Aluminium Foil, Blister Aluminium Foil, PVC Film etc. and secondary packing materials i.e. Cartons, labels, Leaflet shipper etc.

RESPONSIBILITY

Quality Control Executive/Officer

ACCOUNTABILITY

Quality Assurance Manager

PROCEDURE

On receipt of the Goods Receipt Note {GRN} from the Stores check the detail given on GRN and note the details of GRN in Packaging Material Sample Inward Register kept in Packing Material Testing Lab. Note down the Lot number as Analytical Reference number(A R No.) and the supplier’s Lot No. (if any) shall be considered as Batch number.

Based on the number of containers listed in GRN select the number of packages to be sampled as per the sampling plan given in Table -1a.

Enter the details of sampling containers and print out “SAMPLED” label.

Go to the appropriate “UNDER TEST” packaging material storage area and identify the material to be sampled from the label on the pack.

Ensure that the warehouse pastes the “UNDER TEST” labels correctly.

Verify the number of packages as mentioned in GRN.

Check the packing condition of the material and the details mentioned on the labels.

In case of any discrepancy in above step, inform the Quality Assurance Manager and the Warehouse In-charge for corrective action.

Sampling of Primary & Secondary packing materials:

Open the packages carefully and observe the material for any abnormality. In case the packing material is found in damaged condition, the same shall be informed to Manager QA.

After decision of Manger QA the material shall be further segregated or rejected.

In case of segregation the packs found in good condition shall be sampled, the remaining quantity shall be rejected. Prepare the rejection note for damaged containers / roll / packs and paste “REJECTED” label and ensure that such containers/packs/rolls are transferred to rejected area.

Withdraw the samples randomly from different containers equal to sample size as per  Table -1b.

Close the containers to be sampled with the help of BOPP Tape/ties.

Protect the samples from external contaminants like dust, water, and direct sunlight during sampling and testing operations.

Paste the ” SAMPLED” label (As per specimen given in this SOP) on the containers from which the sample is collected.

Carry out testing of the packaging material as per the laid down specifications of the   respective material.

Record the dimensions observed for the required number of samples as specified in individual Physical Inspection Report.

Inspect the total number of samples of packaging materials based on Critical, Major or Minor visual defects. These defects are detailed on the format of individual Physical inspection reports.

Note down the total number of defects, which are categorized under the headings critical, major and minor.

Compare with the accept and reject numbers against the quantity of number of samples collected from Table 1 b.

If the defects in any category is equal to or more than reject number, inform the Quality Assurance Manager for rejection of the consignment.

All excess packaging materials after completion of testing and reporting shall be destroyed. 

Table 1-a

No. of Cases, Rolls or Boxes or Bags in a lot Cases, Rolls or Boxes or bags to be

sampled

1-8 2
9-15 3
16-90 5
91-150 8
151-280 13
281-500 20
501-1200 32

 

Table 1-b

 

MIL – STD – 105 D SINGLE SAMPLING PLAN, GENERAL INSPECTION LEVEL – I

(NORMAL INSPECTION)

Batch or Lot Size (Nos.) Sample Size (Nos.) AQL=0.25 % AQL=0.40 % AQL=1.0% AQL=2.5% AQL=4.0%
A R A R A R A R A R
2-8 2 0 1 0 1 0 1 0 1 0 1
9-15 2 0 1 0 1 0 1 0 1 0 1
16-25 3 0 1 0 1 0 1 0 1 0 1
26-50 5 0 1 0 1 0 1 0 1 0 1
51-90 5 0 1 0 1 0 1 0 1 0 1
91-150 8 0 1 0 1 0 1 0 1 1 2
151-280 13 0 1 0 1 0 1 1 2 1 2
281-500 20 0 1 0 1 0 1 1 2 2 3
501-1200 32 0 1 0 1 1 2 2 3 3 4
1201-3200 50 0 1 1 2 1 2 3 4 5 6
3201-10000 80 0 1 1 2 2 3 5 6 7 8
10,001-35000 125 1 2 1 2 3 4 7 8 10 11
35001-150000 200 1 2 2 3 5 6 10 11 14 15
150001-500000 315 2 3 3 4 7 8 14 15 21 22
Over 500000 500 3 4 5 6 10 11 21 22 21 22

NOTE :

  • In case of Aluminium Foil, Blister Aluminium Foil, Box Strapping Roll, PVC Film & Shrink Film, take out one meter of sample from each box sampled as per Table I -a.
  • In case of Aluminium foil use only three samples for Gram mage testing.
  • In case of BOPP tape & Polybag (for dispensing purpose) take out one sample from each box sampled as per Table I -a.
  • This sampling plan will not be applicable for packaging materials like corrugated boxes, corrugated trays, partition plates etc. For these items three number of samples will be drawn.
  • – From Military Standard, sampling procedures and tables for inspection by attributes, US Dept. of Defence, MIL-STD-105 D, 1963.

A 9 -

A 7 -

A 8 -

About Pharmaceutical Guidanace

Ms. Abha Maurya is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 18 years of rich experience in pharmaceutical field. During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube

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