SOP for Sampling of Packing Material

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Standard Operating Procedure (SOP) for the sampling of packing material (Primary Packing Material, Secondary Packing Material, and Tertiary Packing Material).

Procedure for Sampling and AQL of Packing Material

PURPOSE:

  • The purpose of this SOP is to define the procedure for sampling and acceptance Quality level of packing materials.

SCOPE:

  • This SOP is applicable for sampling and acceptance Quality level of all primary, secondary and tertiary packing materials at the quality control department of the pharmaceutical drug manufacturing plant.

DEFINITION- SOP FOR SAMPLING OF PACKING MATERIAL:

  • Primary Packing Material: The Packing Material, which is in direct contact with product for e.g: Foil, PVC, PVDC, bottles, etc.
  • Secondary Packing Material: The Packing Material which contains primary unit pack or pack-insert for e.g Show box, Package inserts, etc.
  • Tertiary Packing Material: The Packing Material, in which secondary unit pack contained is tertiary
  • packing material e;g corrugated box etc.

7.0   PROCEDURE FOR SAMPLING OF PACKING MATERIAL:

  • Sampling of Packing Materials:
  • On receipt GIM from Packing material stores, QC section head or designee makes an entry in the in packing material inward register.
  • QC officer shall ensure that stores have affixed the “Quarantine” labels on all the containers/boxes/rolls of packaging material received under a consignment,
  • Excluding corrugated box, where affix the quarantine labels on bundles wise is required and verify the materials against the GIM for quantity, no. of rolls/packs, conditions of the consignment.
  • Use gloves and nose masks during sampling of packing material(where required).
  • At the time of show box sampling, check for each multi up’s sheet.
  • Sampling shall be done by A.R. No., Sampling of two or more A.R. No. should not be done simultaneously.
  • Necessary care to be taken to prevent mix up of the different types of material during sampling.
  • Check the following identity during sampling of the consignment like name of the material, name of the manufacturer, qty. received, the total number of rolls & compare with the GIM.
  • Also, ensure that the supplier status label shall be affixed on all the containers/boxes/rolls by the supplier.
  • Collect the samples randomly by opening different packs as per Military Standard 105 E.
  • After sampling put the ‘SAMPLED’ stamp in sampled packs (containers/boxes/rolls) in ‘Black ink’ on the `Quarantine’ label affixed on each pack in such a way that more than half stamping on quarantine label and remaining on packs (boxes/rolls/containers).
  • Stamping shall be done only for those packs that are sampled with the sign. and date of sampling and keep the material at designated place (At the respective location code, if specified in GIM).
  • Do not mark the `SAMPLED’ stamp where the sample is supposed to return to the packing material store.
  • During visual inspection of the consignment, the material should be free from visual defects like…
    • Improper printing,
    • Improper pasting,
    • Alignment of printing,
    • Loose winding or telescopic,
    • Wet & damaged,
    • Objectionable odor,
    • Cut, dent, damage core or edge,
    • Wrinkles in case of foils,
    • PVC or PVC coated PVDC film,
    • Sticking of show boxes, oil, grease, dirt, dust, fiber particles, stone, insects, etc.
  • Remove the minimum 3 meters of
    • Printed Aluminium foil,
    • Plain Aluminium foil,
    • PVC film and
    • PVC coated PVDC film for visual inspection
  • Then cut a minimum 3 meters of printed Aluminium foil and 2 meters of plain Aluminium foil, PVC film and PVC coated PVDC film for complete analysis in the laboratory as per sampling plan.
  • For show box, package insert, corrugated box, printed pressure sensitive labels, HDPE bottles, BOPP tapes, poly bags, applicator, etc. sample withdrawn for visual inspection and complete analysis as per sampling plan.
  • Packing material ‘Visual inspection checklist and sampling report of packing material’ (ref. Attachment – 2) shall be filled during sampling.
  • Spot analysis of packing material during sampling.
  • Physical Appearance of the consignment (Improper packing, dust, dent, damage core, wet condition, etc.)
  • Visual Inspection of the sample (Printing clarity/alignment, loose winding/telescopic, wrinkles, improper pasting/sticking, objectionable odor, rough edges, oil, grease and dirt, fiber particles, etc.)
  • Sampling Scheme of Packing Material as per AQL:
  • Number of packs to be sampled from the total number of packs received as per table – 1.
  • Number of samples to be taken for visual inspection and for complete analysis as per table – 1A.
  • For visual inspection of AQL, consider sample size from the consignment as given in table -1B and record observations in the ‘visual inspection checklist and Sampling report of packing Material’. Ref. attachment-2.
  • The visual inspection of samples shall be carried out in stores for Acceptance Quality Level (AQL) for acceptance criteria of defect attributes like Critical defects 0 %, Major defects 1.0 %, and Minor defects 2.5 % as per details given in Table- 1C.

                 Table – 1: Number of packs to be sampled from the total number of packs received.

Total no. of packs receivedTotal no. of packs to be sampled
2 to 82
9 to 153
16 to 255
26 to 508
51 to 9013
91 to 15020
151 to 28032
281 to 50050
501 to above80

Table – 1A: Number of samples to be taken for complete analysis & for visual inspection.

Batch or Lot Size (Number)Samples for visual inspectionSamples for complete analysis
2 – 822
9 – 1533
16 – 2553
26 – 5084
51 – 90135
91 – 150205
151 – 280327
281 – 500508
501 – 12008010
1201 – 320012512
3201 – 1000020015
10001 – 3500031519
35001 – 15000050023
150001 – 50000080029
500001 and over125036

Table – 1B: Sampling plan for Visual Inspection

      Lot sizeSample sizeAcceptance criteria  (Normal inspection)
Critical 0 %Major 1.0 %Minor 2.5 %
ARARAR
2 to 82010101
9 to 153010101
16 to255010101
26 to 508010101
51 to 9013010112
91 to 15020010112
151 to 28032011223
281 to 50050011234
501 to 1,20080012356
1,201 to 3,200125013478
3,201 to 10,00020001561011
10,001 to 35,00031501781415
35,001 to 150,0005000110112122
150,001 to 500,0008000114152122
500,001 and over12500121222122

A= Acceptance No.    R= Rejection No.

Table-1C: Acceptance Quality Level (AQL) Defects Criteria for Visual Inspection

Procedure: Visually inspect number of samples as per the table 1B : Military standard 105    E.
Critical defects 0%: A critical defect is one that will render the finished product unsafe. Because this represent a potential risk to the patient. For acceptance and rejection refer Table 1B. Major defects 1.0% : A major defect is a defect, other than a critical defect, that is likely to cause non-conformance of product during manufacturing,testing, shipment, storage or use. Such failures do not constitute a potential risk to the patient. For acceptance and rejection refer Table 1B. Minor defects 2.5% : A minor defect is a non-conformance that may detract product elegance, but is expected to have little or no effect on the suitability of the Finished Product for its intended use. For acceptance and rejection refer Table 1B.

(Sampling of Packing Material)

Material NameCritical defectsMajor defectsMinor defects
Printed Show boxMixing of show box other than mentioned productLocking defectsImproper Creasing
Text matter missing / colour missingImproper pastingFolding (Improper)
Embossing missing  Sticking of cartonsColour shade variation
Smudgy Printing/ Shifting of text matters
Wet and dirty cartons

(Sampling of Packing Material)

Plain show boxMixing of show box other than mentioned productlocking defects Improper pastingImproper Creasing
Folding (Improper)
Colour shade variation
Sticking of cartons
Wet and dirty cartons

(Sampling of Packing Material)

Printed LabelsMixing of labels other than the mentioned product.Improper pastingColour shade Variation
Text matter missing / colour missingSmudgy Printing / Shifting of text matters
Wrong winding directionImproper cutting
Wet and dirty labels

(Sampling of Packing Material)

Printed Package Inserts (Leaflets)Mixing of leaflets other than the mentioned product.Improper cuttingColour shade Variation
Text matter missing / colour missingSmudgy Printing
Hole or cutTorn leaflets
Shifting of text matters

(Sampling of Packing Material)

Poly bagsMixing of Poly bag other than mentioned productHole / cut defectsBase information
Extraneous dust or particulate matterBottom sealing
Wet and dirty

(Sampling of Packing Material)

BOPP Tape (Printed / Plain)  Extraneous dust or particulate matterTornColour shade Variation
Missing of company Logo (If applicable)Core damaged
Stains

(Sampling of Packing Material)

Corrugated Boxes (Shipper)  Mixing of shipper other than mentioned productTorn and damaged boxCracks developed on the edges.
Layer separation
Rusted staplesWet and dirtyColour shade Variation
Silica gelPresence of Extraneous matterFinishing of canisterBase formation

(Sampling of Packing Material)

Material NameCritical defectsMajor defectsMinor defects
HDPE bottles /caps / spoon/ tablet applicatorMixing with other than mentioned productDamagedColour shade variation
Extraneous matter
Presence of Black particlesRough Edges
Presence of dents
Cracked containers, Hole or cutWet and dirty

(Sampling of Packing Material)

Plain Alu. Foil(Stip & Form Pack) / PVC Film/PVC- PVDC FilmMixing of foil/films roll other than mentioned productLoose winding and Telescopic windingColour shade variation
Poorly damaged coreWrinkles & brittle
Wrong winding directionDifferent colour stains on the foil
Wet and dirty

(Sampling of Packing Material)

Printed Aluminium FoilMixing of foils roll other than mentioned productLoose winding and Telescopic windingColour shade variation
Text matter & colour missing or cuttingSmudgy printing / shifting of text matters
Poorly damaged coreDifferent colour stains on the foilNumber of joints (NMT 2)
Wrong winding direction
Wet and dirty

                 * Functionality test as per the respective specifications

  • Randomly select the boxes and withdraw approximately equal quantities of sample from the selective boxes.
  • Check the samples as per AQL. After the checking of Acceptance Quality Level of Packing material put the samples (except the material which are defective) in same boxes in such a way that the sample quantity of boxes shall remain same as per initial quantity.
  • Left over sample shall be kept in last sampled box.
  • E.g ; Suppose 25 packs of show box are received and received quantity is 10000 as per GIM, then according to Military Standard 105 E, total no. of box to be sampled is 5 and total sample quantity is 200.
  • So collect 40 nos. show box from each selected box. Check the each ups of multiple’s sheet and perform the spot analysis. After spot analysis, segregate the 15 nos. show box for QC analysis.
  • Return the same withdrawn show box quantity (40 nos.) to respective sampled box (1 to 4 no. box) and remaining left over show box (25nos.) shall be kept in last sampled box (5 no.).
  • For complete testing of packing material as per respective specification, draw the quantity of the samples required for analysis. Perform the complete analysis on number of samples as per table 1A. BOPP tape, poly bag etc. where complete testing shall be done on 3 numbers.
  • In case of silica gel & BOPP tape, samples are return back to PMS after analysis.
  • In case of corrugated box, visual inspection shall be done as per AQL and dimension shall be checked for 3 numbers of corrugated box at the time of AQL sampling.
  • Dimension shall be mentioned in attachment-2 (Visual inspection check list and sampling report of packing material).
  • Close inner and outer packing properly after sampling with imprinted QC SAMPLED BOPP tape affix “sample” label on sampled materials. Ref. annexure-2.
  • Deduction of sample quantity in ERP/SAP System (Sampling of Packing Material):
  • In case of plain/printed foil, PVC, PVC coated PVDC film, poly bag etc., the    sample quantity remove in meters and numbers form but sample quantity shall be deducted in ERP/SAP system in Kilogram form as per below.
Sr. No.Material NameThicknessSample quantity in meters/nos.Sample quantity in Kgs. Approx.
1Printed Alu. blister foil0.025 mm3 meters/Roll0.05 Kg.
2Printed Alu. strip foil  0.04 mm3 meters/Roll0.12 Kg.
0.03 mm3 meters/Roll0.1 Kg.
3Printed paper based laminate foil0.02 mm3 meters/Roll0.12 Kg.
4Plain Alu. Blister foil0.025 mm2 meters/Roll0.03 Kg.
5Plain Alu. strip foil0.04 mm2 meters/Roll0.1 Kg.
0.03 mm2 meters/Roll0.08 Kg.
6Alu-Alu form pack foil0.045mm2 meters/Roll0.12 Kg.
7PVC Film0.25 /0.3/ 0.35 mm2 meters/Roll0.15 Kg.
8PVC coated PVDC film0.25 /0.3/ 0.35 mm2 meters/Roll0.2 Kg.
9Poly Bag (All size)150/200 gauge3 nos.0.15 kg.
  • Acceptance Criteria:
  • All results should comply as per the respective specification.
  • In case of the sample does not complies the AQL then material shall be rejected.

8.0   ANNEXURES OF SOP – SAMPLING OF PACKING MATERIAL:

Annexure-1: Packing Material Inward Register.

Prepare the logbook with the following table contents…

  • SR. No.
  • GIM Date
  • GIM receipt Date
  • Item Name
  • Item Code
  • GIM No.
  • A.R. No.
  • Receipt Qty.
  • Mfg. by/ Supplied by
  • Sampled by / Date
  • Analysed by / Date
  • Released Status
    • Approved by / Date
    • Rejected by / Date
  • Remarks

Annexure-2: Visual Inspections Checklist and Sampling Report of Packing Material.

  • Item Name                  :
  • Item Code                               :
  • GIM No.                     :
  • A.R. No.                     :
  • Mfg. / Supplier Name :
  • Date of material receipt          :
  • Quantity Received                  :
  • Number of packs received      :
  • Number of packs sampled      :
  • Visual inspection quantity      :
  • Quantity for complete analysis           :
  • Spot Analysis of the sample (Put mark)
  • Physical Appearance            :Complies / Does Not Complies
  • (Improper packing, dust, dent, damage core, wet condition, etc.)
  • Visual Inspection (As per AQL)      : Complies / Does Not Complies / NA
  • (Printing clarity/alignment, wrinkles, loose winding, telescopic, improper, pasting, sticking, objectionable odor, rough edges, oil, grease and dirt, fiber particles, etc.)
  • Storage condition                    : Complies / Does not comply
  • Others (if any)             :

Annexure-3: Sampled Stamp.

  • Sampling of Packing Material

Annexure-4: Sample Label.

Quality Control Department SAMPLING OF PACKING MATERIAL
Item Name …………………………………………………………..
Batch No. ……………………… A.R. No. ……………………..
Sampled quantity ………………………………………………..
Roll / Pack No. …………………………………………………….
Mfg. / Supplied by ……………………………………………….
Signature …………………….. Date……………………………..

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