SOP for Sampling of Packing Material - Pharmaceutical Guidelines

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

Table of Contents

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 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.