procedure for Sampling of Packaging Materials SOP

Standard Operating Procedure For Sampling of Packaging Materials

  1. Objective

To lay down a procedure for Sampling of Packaging Materials. 

  • Scope

This SOP is applicable in Quality Control for sampling of Packaging Materials.  

  • Responsibility

QC Chemist                : Follow the procedure and maintain record as applicable.   

  • Accountability

Head Quality Control  : System Compliance

  • Procedure:                                                                                                      
    • QC chemist shall receive the Goods Receipt Note (GRN) from store and enter the GRN details in packing material inward register.
    • Check the consignment in quarantine area with duly affixed “Quarantine Label” by warehouse.
    • 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.
    • 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”. 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:
    • 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, .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. 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 . Collect the sample in a poly bag with label.
    • 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 material.
    • Procedure for Stringent sampling in case of any full / partial rejection in previous consignment:
      • 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 .
      • 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 .
      • 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:
      • Sampling of primary packing material 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.   
        • Operate 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 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 , 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.
  • Sampling of Secondary packaging material 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.
  • In case of 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 each lot, close each container of the lot with tape or tie with cable.               
  • Sampling of shipper, Shrink wrapping Film, BOPP tape, measuring cups other Material shall be carried out in their respective Quarantine Area.
  • Prior to sampling of the above material 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 each lot 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).

  1. Critical defect are those which lead to adulteration or misbranding of the product and likely to cause product unfit for use.
  2. Major defect are those which can cause interference with machine operation.
  3. Minor defect are unlikely to cause any product damage or result in the product being unfit for use.
    1. 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.
    1. After sampling 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).
    1. 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. Retest period shall be updated and controlled.
  • Sampling for retesting of packaging material shall be done as procedure defined above in point and retained sample shall not be taken.
    • Follow SOP for testing, retesting and release of packing materials.
    • 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.
  • Annexure (S):
  • NA
  • Reference (S)

            In-house

  • Glossary  

SOP    :  Standard Operating Procedure

QC      : Quality Control

QA       : Quality Assurance

PM      : Packaging Material

No.      : Number

GRN    : Goods Receipt Note

RFU    : Ready for Use

RLAF   : Reverse Laminar Air Flow

Alu       : Aluminum

AQL     : Acceptance Quality Level

ANSI   : American National Standard Institute

COA    : Certificate of Analysis

BOPP  : Biaxial Oriented Polypropylene

PVC    : Poly Vinyl Chloride

PVDC  : Poly Vinyl Dichloride

HDPE  : High Density Poly Ethylene

ST       :  Store

C-Box : Corrugated Box

  • Revision History:

NA

Bhanu Pratap Singh

BHANU PRATAP SINGH IS EXPERIENCED IN PHARMACEUTICAL, AUTHOR AND FOUNDER OF PHARMACEUTICAL GUIDESLINE (WWW.PHARMAGUIDESLINE.COM), A WIDELY READ PHARMACEUTICAL BLOG SINCE 2019. EMAIL:- INFO@PHARMAGUIDESLINE.COM

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