Sampling of Packaging Materials – Procedure

Standard Operating Procedure (SOP) for sampling of packaging materials (i.e. Aluminum Foil Printed & Plain / Aluminum Foil Forming / PVC / PVDC / HDPE Bottle / Glass Bottle/ Cap Child Resistant /Cap Non Child Resistant / PP Cap / Catch Box / Catron / Label etc.

Procedure for Sampling of Packaging Materials

1.0   Objective

    • To lay down a procedure for Sampling of Packaging Materials. 

2.0   Scope

    • This SOP is applicable in Quality Control for sampling of Packaging Materials at pharmaceuticals drug manufacturing plant.  

3.0   Procedure for Sampling of Packaging Materials :

    • QC chemist shall receive the Goods Receipt Note (GRN) from store and enter the GRN details in packing material inward register as per Annexure-I.
    • Check the consignment in quarantine area with duly affixed “Quarantine Label” by warehouse as per SOP for Receipt and storage of packaging materials.
    • QC chemist shall ensure that the consignment is placed in quarantine area on pallets and delivered consignment is received from approved vendor.
    • Ensure that the packets/Boxes are cleaned.
    • Ensure that the vendor approved status label has been crossed. If not, cross it.
    • QC chemist shall print the “UNDER TEST” label and affix on the containers (Receipt and storage of packaging materials)
    • Analyst shall prepare and affixed “SAMPLED” label for the containers/Boxes/Bundles / Rolls/Bag to be sampled.
    • If any discrepancy observed during verification of materials, information shall be given to Head QC and Head QA/Designee for necessary action.
    • Record the details of the consignment in “Sampler’s remarks sheets of packaging material” (Refer Annexure -II).
    • Separate sampler’s remark sheet shall be used for each batch.

    • Check and ensure that the container(s) are affixed with manufacturer’s /Supplier’s label with following details:Sampling of Packaging Materials
      • Name of Material.
      • Quantity: Nos. / weight
      • Number of packs received.
      • Manufacturers / supplier’s name and address.
    • In case any discrepancy is observed, check the details in delivery challan.
    • Select the number of containers to be sampled, as per Annexure III (Number of containers sampled in a lot).Whenever there is a loose box, sampling person has to collect the sample from loose box, also.
    • Check the Physical condition of the consignment as exterior of all packs for any damage or insects or possible contamination if any and record the observation in the “Sampler’s Remark sheet of Packaging material”.
    • In case of bottles, withdraw the sample in such a manner so that sample should be representative from each mold no. printed on the bottom.
  • From the containers to be sampled, the material is checked for Attributes and variables:

    • Attributes:
    • These are parameters like color, shade, printability, presence of dirt and stain, alignment, presence of spots etc. Attributes, are parameters which shall be checked visually.
    • Attributes have indirect impact on packaging material.
    • Variables:
    • These are the parameters like dimension, Grammage, thickness etc.
    • Check the required numbers of samples for attribute as per ANSI Z.1.4 (refer Annexure – IV- Table ANSI Z 1.4 Single Normal Procedure (AQL Chart).
    • Check the attribute in sampling area. For Secondary & Tertiary Packaging materials, collect almost same number of units from each container.
    • For variable check, collect equal number of sample from each unit of packed container for complete Analysis (Annexure V- List of Number of sample to be withdrawn for Analysis).
    • Collect the sample in a poly bag with label “Sample for Analysis” as per Annexure VI.
      Advertisement
    • The remaining samples are put back in the consignment.
    • Record the sampled quality, attribute check quantity, variable check quantity in the sampler’s remark sheet (refer Annexure – II) of packaging materials.
  • Procedure for Stringent sampling in case of any full / partial rejection in previous consignment – Packaging Materials Sampling:

    • Analyst shall check before sampling, whether there was any rejection of same material from same vendor in previous supply.
    • Check the required number of samples for attribute as per ANSI Z 1.4 (refer Annexure – V) one level up.
    • Check the attribute in sampling area. For Secondary & Tertiary Packaging materials, collect almost same number of units from each container.
    • For variable check, collect equal number of sample from each unit of packed container “Sample for Analysis” as per Annexure IV.
    • The remaining samples are put back in consignment.

Note: Stringent sampling shall be applied for three consequent supplies of respective vendor.

    • In case of printed packaging materials like Cartons, Literatures and Labels, check and ensure that specimen is displayed on the outer surface of each pack.
    • Check and ensure that bottles are stacked properly.
    • If any deviation is observed mark on GRN and inform to Head QC.
    • Sampling – Packaging Materials:

    • Sampling of primary packaging materials i.e. aluminum Foil Printed & Plain / Aluminum Foil Forming / PVC / PVDC / HDPE Bottle / Glass Bottle/Pet Bottle/Cap Child Resistant / Cap Non Child Resistant / Desiccant Canister / Jar/ Poly bag /Dropper/PVC & PP Cap:
    • In case of Aluminum Foil Printed & Plain/Aluminum Foil Forming /PVC/PVDC /HDPE Bottle/Glass Bottle/Pet Bottle/Cap Child Resistant/Cap Non Child Resistant /PP Cap/ carryout the sampling activity under the portable LAF.
    • Cleaning of LAF shall be performed after completion of the sampling activity and recorded.
    • Check the consignment details for correctness of the details mentioned on the “Under Test” Labels.
    • In case of discrepancies intimate to Head QC.
    • Wear the hand gloves and nose mask during sampling activity.
    • Carryout the Sampling of Packaging Materials of each consignment separately one after the other.
    • Only one material will be taken into sampling area and after sampling, area will be cleaned properly before switching over to next sample.
    • After completion of the sampling of each lot as per Annexure V, close each container of the lot with tape or tie with cable and shift the material to under test area in warehouse.
    • Enter the details in the Equipment Log Sheet.

Note: Sampling of Primary Packaging Materials for microbiological examination shall be done as per SOP.

  • Sampling of Secondary packaging materials i.e. Carton, catch box, Label and leaflet/Literature:

    • In case of Secondary packaging material carryout the sampling activity in their respective quarantine area.
    • Open the shipper boxes carefully by peeling off the BOPP tape and draw sample. Seal the boxes – using plain BOPP tape.
    • Check the consignment details for correctness of the details mentioned on the “Under Test” labels.
    • In case of discrepancies intimate to Head QC.
    • For the label and literature, care should be taken while opening the packs and inner bundles.
    • In case of cartons, withdraw the cartons in such a manner so that sample should be representative from each punch No. printed on the carton.
    • After completion of the Sampling of Packaging Materials of each lot as per Annexure V, close each container of the lot with tape or tie with cable.
  • Sampling of shipper, Shrink wrapping Film, BOPP tape, measuring cups other Packaging Materials shall be carried out in their respective Quarantine Area.

    • Prior to sampling of the above packaging materials clean the number of container to be sampled with the help of dry duster. Wear the hand gloves and mouth mask during sampling activity.
    • Wear the hand gloves and mouth mask during sampling activity.
    • After completion of the Sampling of Packaging Materials of each lot as per Annexure V, close each container of the lot with tape.
    • Acceptance Quality Level (AQL):

    • Appropriate Acceptance Quality Level for defects can be classified as Critical, Major and Minor (Annexure IV).
    • Critical defect are those which lead to adulteration or misbranding of the product and likely to cause product unfit for use.
    • Major defect are those which can cause interference with machine operation.
    • Minor defect are unlikely to cause any product damage or result in the product being unfit for use.
    • If Packaging Material dimension in out of limit found in minor variation form specification, the send samples for machine trial.
    • If machine trial report found satisfactory then release the material.
    • After Sampling of Packaging Materials QC chemist should affix the duly signed florescent yellowish green coloured SAMPLED Label on the container, near right corner of the under test label from which the  drawn (except bottles & c-box).
    • Retained samples:

    • Specimen of all printed/unprinted packaging material carton, catch box, catch over, label and Literature are retained 2 numbers along with respective Analytical report. PVC, PVDC, Blister foil, Alu foil, Alu forming foil, 25cm from each sampled rolls shall be retained along with respective Analytical report.
    • All retain samples shall be preserved up to 5 years along with respective analytical report.
    • Retest of Packaging materials :

    • Retest period of primary packaging material and printed packaging material (such as Aluminum Foil Printed & Plain / Aluminum Foil Forming / PVC / PVDC / HDPE Bottle / Glass Bottle/ Cap Child Resistant /Cap Non Child Resistant / PP Cap / Catch Box / Catron / Label) shall be assigned 02 years. 
    • Sampling for retesting of packaging materials shall be done as procedure defined above and retained sample shall not be taken.
    • Before affixing the label on the container / in core of roll, QC Chemist shall clean the area using clean cloth.
    • QC chemist shall apply light hand pressure on the label for proper affixing.
    • Expiry of primary packaging material and printed packaging material shall be four years from the date of receipt or as specified by the manufacturer.
    • If expiry date is not given by the manufacturer the material shall be rejected during second retest.

4.0   Annexure – Sampling of Packaging Materials :

Annexure-I: Packing Material Inward Register

Sr. No.

Date GRN No. Item Name Batch No. Manufacture name

Quantity Received

Sample received on

A.R No. Allotted To Approved By Status & Date

Remark

Annexure – II : Format for Sampler’s Remark of Packaging Material.

1.      Name of Item:
2.      Name of manufacturer / Supplier:
3.      Item Code: Batch No.:
4.      G.R.N No.: No. of packs / boxes sampled:
5.      No. of packs / boxes received: Quantity Sampled for visual inspection:
6.      Qty per box / pack: Quantity sampled for Testing :
7.      Total Quantity Received: Date of Sampling :
                                                Physical Condition of Consignment
8.      Nature of containers Polythene Bag/ Gunny Bag /Paper Bag / Corrugated Box / Bundles / Rolls / Others…………………..
9.      Physical condition of consignment Satisfactory / Not satisfactory
10.    Source of material Approved vendor / other
11.    Analytical Report (COA) Received / Not Received
12.    Cleaning of surrounding area of consignment Satisfactory / Not satisfactory
13.    Proper Consignment label Affixed by Party Yes / No
14.    Proper Quarantine Label Affixed by Warehouse Yes / No
15.    After sampling resealing of boxes done Yes/ No
16.    Remarks:
Sampled by :

(sign / Date)

Checked by :

(Sign / Date)

Annexure – III : Number of containers sampled in a lot.

Number of Containers in a Consignment Number of Containers to be Sampled
1 to 5 All
6 to 15 5
16 to 25 8
26 to 50 13
51 to 90 16
91 to 280 20
281 to 1200 50
Over 1200 125

Annexure – IV : Table ANSI Z 1.4 Single Normal Procedure (AQL Chart).

Table ANSI Z 1.4 Single Normal Procedure (AQL Chart). 

 

Lot Size

General Level
I II III
2  to 8 02 2 3
9  to 15 02 3 5
16  to 25 3 5 8
26  to 50 5 8 13
51  to 90 5 13 20
91  to 150 8 20 32
151 to  280 13 32 50
281  to 500 20 50 80
501  to 1200 32 80 125
1,201 to 3,200 50 125 200
3,201 to 10,000 80 200 315
10,001 to 35,000 125 315 500
35,001 to 150,000 200 500 800
150,001 to 500,000 315 800 1250
500,001 and OVER 500 1250 2000

REMARKS:-

General Level I –  Applicable for

  • Cap, HDPE/Glass Bottles, Glass vials, HDPE drum, jar, BOPP tape, Measuring cup, Inner Plug, Poly bag, Tri laminate bag, Shipper, Pad, Partition, Tray , Thumb Spray, Dropper, Oral Dosing Assembly, Press in Bottle Adapter, adhesive hot melt, desiccant Canister Silica gel Packet, and Flip off seal, Seal, Seals, Dropper, Inner Plug and other.

General Level II- Applicable for

  • Blister Foil, Glassine Foil, PVC, PVDC, Rubber Closures, Aliminium foil (Plain, Printed and Forming), Blister foil Plain/ Printed, Wrapping Film, Shrink Film, Purified Cotton.

General Level III- Applicable for

  • Carton, Catch box, catch cover, Labels, Leaflet (Literature).

Annexure – V : List of Number of sample to be withdrawn for Analysis.

S. No. Name of Material Number of sample to be withdrawn for analysis
1. HDPE Bottles/ PET Bottles / Jars 25 Nos
2. Cap Child Resistant 25 Nos
3. Cap Non Child Resistant 25 Nos
4. Blister Foil/ Aluminum Foil Plain/ Printed For 1 Roll                  :  2 Meter

 

More Than 1 Roll    :  1 Meter from each roll

5. PVC / PVDC
6. Alu Foil Forming
7. Purified Cotton 100g
8. Carton / Catch Box/ Catch Cover 25 Nos.
9. Label/ Leaf List (Literature) 25Nos.
10 Poly bags / Trilaminate bag 10 Nos.
11. BOPP Tape 1No.
12. Shipper / Partition / Pad 1No.
13. Desiccant Canister (silica gel) 1g/2g/3g/5g                     : 20Nos

10g and above                : 15Nos

14. Dispenser 25 Nos.
15. Shrink wrapping film 1 Meter from each roll
16. Dropper 25 Nos.
17. HDPE Drum 1No.
18. Adhesive hot melt 100g
19.  Glass Bottles 25 Nos.
20. Measuring cup/ PP cap/ Induction seal cap 25 Nos.
21. Tray 20 Nos.

Annexure – VI : Sample for Analysis.

SAMPLE FOR ANALYSIS

 Name of Material        :

 Batch No.                    :

 G.R.N. No.                   :

 Date of Sampling        :

 Signature                     :

pharmabeginers

Janki Singh is experienced in Pharmaceuticals, author and founder of Pharma Beginners, an ultimate pharmaceutical blogging platform. Email: [email protected]

Leave a Reply