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WAR-050 Sampling of Components and Printed Materials

DepartmentWarehouseDocument noWAR-050
Prepared by: Date: Supersedes: 
Checked by: Date: Date Issued: 
Approved by: Date: Review Date: 

Document Owner

Warehouse Manager

Affected Parties

All warehouse staffs working as a sampler.

Purpose

To describe the procedure and schedules for sampling components and printed material.

Scope

Warehouse sampling of Packaging Materials by Samplers.

Definition

Pre sampledSample coming from the approved supplier in a separate box.
Packaging materials 
Sydco ID labelCompany Identification label

Related Documents

Form-010Sample Request Form
Form-090Sampled Stickers
TEM-150Packaging Material Specification and Test Report
WAR-005Receipt of Incoming Goods

 

EHS Statement

Take care when using knives.

Due care to be taken when assessing the stability of loads of packaging materials that may have shifted and become unstable in transit from the supplier.

Gloves and safety glasses must be worn when handling 70% IPA (Alcohol) where needed.

Procedure

1. Sampling of Components

Sampling of components and printed material represents a substantial contamination risk.
The Sampler must make every effort to ensure that the material is not contaminated by the sampling environment, including cross-contamination from other components and printed material.

Note: For every product sampled, check that the GRS matches the goods, including the correct manufacturer’s batch number, quantity, and material number.  Check also that the product is in good order.

Note: The person who generates the Goods Receipt Slip must not sample the goods as per cGMP.

Note: All samples are to be delivered to the Laboratories ASAP.

2. Packaging Materials-Sampling

Warehouse sampler to print a Packaging Material Specification and Test Report for the corresponding printed material codes and start sampling as described in the specification report.

Find the lot size of the product on the left hand column of the sampling table located in Section 9 of this SOP. The sampling quantity is located in the adjacent right hand column.

To determine the sample size required, utilise Sampling Table in Section 9 as per example:

Amount Received = 30,000

Table I: 10,001-35,000 = 125 units.

SAMPLING PLAN

For pre-sampled labels:

The boxes containing the samples are stamped with “Samples Enclosed”.

Cut the box open at the top, open the plastic bag and collect the samples. Place the samples in a bag and label with Sydco ID label collected from warehouse.

Each box of labels MUST be labelled with a Sydco label. The label MUST NOT cover the Manufacturer’s Label, but still must be placed on the front of the box.

For 2 or less rolls, you will need 4 labels from EACH roll

For 3 or more rolls, you will need 3 labels from EACH roll.

To take a sample:
Cut the box at the top, open the inner plastic bag and remove the top roll of labels.

Using a safety knife or a pair of scissors, cut the samples from the roll and place them into a sample bag labelled with Sydco label collected from warehouse.

Put the roll back into the box, close the bag and re-seal the box.

Stick a “SAMPLED” sticker on the outer of each box sampled, ensuring that the sticker is not covering any other labels

Place the samples in a bag and label with Sydco label collected from warehouse.

 

3. Printed Labels

4. Printed Cartons

4.1.             Cartons

SAMPLING PLAN

For pre-sampled cartons:

The boxes containing the samples are stamped with “Samples Enclosed”.

Cut the box open at the top, open the plastic bag and collect the samples.

 

Place the samples in a bag and label with Sydco ID label collected from warehouse.

Each box of labels MUST be labelled with a ID label. The label MUST NOT cover the Manufacturer’s Label, but still must be placed on the front of the box.

For less than 10 boxes, you will need 3 cartons from each box, minimum of 8 cartons in total.

For greater than 10 boxes received, you will need 3 cartons from the n+1 boxes where n represent the no. of boxes.

To take the sample…

Cut the box at the top and remove the required number of samples.

Re-seal the box and label it with an “SAMPLED” sticker and Sydco label ensuring that it does not cover any other labels on the box.

Label the box with a “Sample Partial” sticker and fill in the required details.

Place the samples in a bag and label with Sydco label collected from warehouse.

 

4.2. Corrugated Cardboard

SAMPLING PLANNot Sampled

4.2.1. A “Certificate of Analysis” accompanies all packaging shippers.

4.2.2. Detach the certificate and staple it together with the GRS deliver to the lab.

4.2.3. If a certificate is not accompanied with the product, contact purchasing department to follow it up with the supplier.

5. Leaflets

SAMPLING PLAN

For pre-sampled cartons:

The boxes containing the samples are stamped with “Samples Enclosed”.

Cut the box open at the top, open the plastic bag and collect the samples. Place the samples in a bag and label with Sydco ID label collected from warehouse.

Each box of labels MUST be labelled with a ID label. The label MUST NOT cover the Manufacturer’s Label, but still must be placed on the front of the box.

Take a minimum total of 8 leaflets from batches containing one or two boxes.

For three or more boxes 3 leaflets are sampled from each box ensuring that samples reflect the contents of the box.

To take a sample…

Cut the box at the top and remove the required number of samples.

Re-seal the box and label it with an “SAMPLED” sticker and Sydco label, ensuring that it does not cover any other labels on the box.

 

Label the box with “Sampled Partial” sticker and fill in the required details.

Place the samples into a sample bag and label with an Sydco label collected from warehouse.

 

6. Plain and Printed Aluminium Foils (printed on one or both side)

SAMPLING PLAN

To take the sample…

If printed foils are received as rolls, these are to be sampled and each roll MUST be labelled with Sydco ID label and four ID labels are applied to each side of the pallet at the lowest point. This is to ensuring that the right label goes with the right roll.

For 10 rolls or less, sample all 10 rolls of printed Aluminium foil.

For 11 or more rolls sample n + 1 rolls.

Samples should be approx. 1.5m in length (not from the outside of roll) and, in the case of a repeatable pattern, should contain at least 15 full patterns.

If foils are received as rolls, the outside box needs to be numbered (from 1 to however many samples taken).  Write the number clearly on the box using a Black marker.  Cut the box open at the top, remove the foil (with the plastic covering) from the box.

Un-wrap the plastic film from the foil and place the foil on the sampling table.  Discard approximately 2 metres of foil from the start of the roll.

Cut the sample from the roll using a safety knife or scissors.

Using a Black marker, write the corresponding number from the box on to the sample (in a top corner).

One Sydco label must be placed on each box, and one on the samples.

Deliver the samples to the lab.

 

7. Bottles

7.1. Glass bottles

SAMPLING PLANNot Sampled

7.2. Plastic Bottles

SAMPLING PLAN

25 bottles taken for sampling.

To take the samples…

Cut the box or boxes open

Wearing gloves, take the required amount of samples

Seal the boxes

Stick a “SAMPLED” sticker on the sampled boxes, writing the new quantity and date.

Place Sydco label on each box and also on the sample bag.

 

8. Polyurethane Foam Disc

SAMPLING PLAN

Take 10 samples from each delivery.

Sampler to inspect the shipper for any signs of damage or contamination.

 

9. SAMPLING TABLE: Use for Packaging Materials

Lot SizeSample Size
2 to 252
26-503
51-905
91-1508
151-28013
281-50020
501-1,20032
1,201-3,20050
3,201-10,00080
10,001-35,000125
35,001-15,0000200
150,001-500,000315
500,001 and over500

 

10. Documentation and Samples

After samples are taken from the newly arrived printed components, warehouse sampler then send the labelled sample containers/bags, GRS slips, the respective blank Packaging Material Specification and Test Report and manufacturer’s certificate of Analysis to the Laboratory for testing.

11. Summary of Changes

Version #Revision History
WAR-050New