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

Procedure for Sampling and AQL of Packing Material

1.0   PURPOSE:

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

2.0   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.

3.0   REFERENCES:

• • In House.

• • Military Standards 105 E.

• • ISO 2859-1: Sampling scheme indexed by AQL for a lot by lot inspection.

• • SOP for General cleaning procedure of sampling area,

• • SOP for Issuance and writing of analytical raw data in Template / Protocol Ref.

4.0   RESPONSIBILITY:

• • The analyst shall be responsible for :

• • To maintain the sampling room as per SOP.

• • To maintain the document as per SOP.

• • Quality Control Head or Designee shall be responsible for:

• • Check the SOP.

• • Give training to all the concerned persons before the implementation of the    

• • To ensure that the cleaning procedure is followed as per SOP.

• • Quality Assurance shall be responsible for:

• • Check the SOP.

• • To ensure the implementation of the system as per SOP.

• • Site Quality Head shall be responsible for:

• • To review and approve the SOP.

• • To ensure the implementation of SOP.

5.0   ABBREVIATIONS USED IN SOP – SAMPLING OF PACKING MATERIAL:

• • AQL: Acceptance Quality Level

• • BOPP: Bi-Oxalic Oriented Poly Propylene

• • COA: Certificate Of Analysis

• • Dept: Department

• • GIM: Goods Inward Memo

• • HDPE: High-Density Polyethylene

• • PMS: Packing Material Store

• • PVC: Polyvinyl Chloride

• • PVDC: Polyvinyl Dichloride

• • QC: Quality Control

6.0   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 received	Total no. of packs to be sampled
2 to 8	2
9 to 15	3
16 to 25	5
26 to 50	8
51 to 90	13
91 to 150	20
151 to 280	32
281 to 500	50
501 to above	80

 

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

Batch or Lot Size (Number)	Samples for visual inspection	Samples for complete analysis
2 – 8	2	2
9 – 15	3	3
16 – 25	5	3
26 – 50	8	4
51 – 90	13	5
91 – 150	20	5
151 – 280	32	7
281 – 500	50	8
501 – 1200	80	10
1201 – 3200	125	12
3201 – 10000	200	15
10001 – 35000	315	19
35001 – 150000	500	23
150001 – 500000	800	29
500001 and over	1250	36

 

Table – 1B: Sampling plan for Visual Inspection

Lot size	Sample size	Acceptance criteria  (Normal inspection)
		Critical 0 %		Major 1.0 %		Minor 2.5 %
		A	R	A	R	A	R
2 to 8	2	0	1	0	1	0	1
9 to 15	3	0	1	0	1	0	1
16 to25	5	0	1	0	1	0	1
26 to 50	8	0	1	0	1	0	1
51 to 90	13	0	1	0	1	1	2
91 to 150	20	0	1	0	1	1	2
151 to 280	32	0	1	1	2	2	3
281 to 500	50	0	1	1	2	3	4
501 to 1,200	80	0	1	2	3	5	6
1,201 to 3,200	125	0	1	3	4	7	8
3,201 to 10,000	200	0	1	5	6	10	11
10,001 to 35,000	315	0	1	7	8	14	15
35,001 to 150,000	500	0	1	10	11	21	22
150,001 to 500,000	800	0	1	14	15	21	22
500,001 and over	1250	0	1	21	22	21	22

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 Name	Critical defects	Major defects	Minor defects
Printed Show box	Mixing of show box other than mentioned product	Locking defects	Improper Creasing
	Text matter missing / colour missing	Improper pasting	Folding (Improper)
	Embossing missing	Sticking of cartons	Colour shade variation
		Smudgy Printing/ Shifting of text matters
		Wet and dirty cartons

(Sampling of Packing Material)

Plain show box	Mixing of show box other than mentioned product	locking defects Improper pasting	Improper Creasing
			Folding (Improper)
			Colour shade variation
		Sticking of cartons
		Wet and dirty cartons

(Sampling of Packing Material)

Printed Labels	Mixing of labels other than the mentioned product.	Improper pasting	Colour shade Variation
	Text matter missing / colour missing	Smudgy Printing / Shifting of text matters
	Wrong winding direction	Improper cutting
		Wet and dirty labels

(Sampling of Packing Material)

Printed Package Inserts (Leaflets)	Mixing of leaflets other than the mentioned product.	Improper cutting	Colour shade Variation
	Text matter missing / colour missing	Smudgy Printing
	Hole or cut	Torn leaflets
		Shifting of text matters

(Sampling of Packing Material)

Poly bags	Mixing of Poly bag other than mentioned product	Hole / cut defects	Base information
	Extraneous dust or particulate matter	Bottom sealing
		Wet and dirty

(Sampling of Packing Material)

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

(Sampling of Packing Material)

Corrugated Boxes (Shipper)	Mixing of shipper other than mentioned product	Torn and damaged box	Cracks developed on the edges.
		Layer separation
	Rusted staples	Wet and dirty	Colour shade Variation

 

Silica gel

Presence of Extraneous matter

Finishing of canister

Base formation

(Sampling of Packing Material)

Material Name	Critical defects	Major defects	Minor defects
HDPE bottles /caps / spoon/ tablet applicator	Mixing with other than mentioned product	Damaged	Colour shade variation
	Extraneous matter
	Presence of Black particles	Rough Edges
	Presence of dents
	Cracked containers, Hole or cut	Wet and dirty

(Sampling of Packing Material)

Plain Alu. Foil(Stip & Form Pack) / PVC Film/PVC- PVDC Film	Mixing of foil/films roll other than mentioned product	Loose winding and Telescopic winding	Colour shade variation
	Poorly damaged core	Wrinkles & brittle
	Wrong winding direction	Different colour stains on the foil
	Wet and dirty

(Sampling of Packing Material)

Printed Aluminium Foil	Mixing of foils roll other than mentioned product	Loose winding and Telescopic winding	Colour shade variation
	Text matter & colour missing or cutting	Smudgy printing / shifting of text matters
	Poorly damaged core	Different colour stains on the foil	Number 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 Name	Thickness	Sample quantity in meters/nos.	Sample quantity in Kgs. Approx.
1	Printed Alu. blister foil	0.025 mm	3 meters/Roll	0.05 Kg.
2	Printed Alu. strip foil	0.04 mm	3 meters/Roll	0.12 Kg.
		0.03 mm	3 meters/Roll	0.1 Kg.
3	Printed paper based laminate foil	0.02 mm	3 meters/Roll	0.12 Kg.
4	Plain Alu. Blister foil	0.025 mm	2 meters/Roll	0.03 Kg.
5	Plain Alu. strip foil	0.04 mm	2 meters/Roll	0.1 Kg.
		0.03 mm	2 meters/Roll	0.08 Kg.
6	Alu-Alu form pack foil	0.045mm	2 meters/Roll	0.12 Kg.
7	PVC Film	0.25 /0.3/ 0.35 mm	2 meters/Roll	0.15 Kg.
8	PVC coated PVDC film	0.25 /0.3/ 0.35 mm	2 meters/Roll	0.2 Kg.
9	Poly Bag (All size)	150/200 gauge	3 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.

• 

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……………………………..