Standard Operating Procedure (SOP)

1. Purpose
To define the procedure for sampling of primary, secondary, and tertiary packing materials to ensure that the materials received conform to the required quality standards before use in production.

2. Scope

• This SOP applies to all packing materials received at [Company/Facility Name], including but not limited to:
• Primary Packing Materials (e.g., bottles, caps, blisters, strips)
• Secondary Packing Materials (e.g., cartons, labels, leaflets)
• Tertiary Packing Materials (e.g., shipper boxes, stretch film)

3. Responsibilities

Quality Control (QC) Personnel:

Perform sampling as per this SOP.

Ensure proper labeling and documentation of sampled materials.

Warehouse/Store Personnel:

Inform QC about incoming materials.

Arrange materials for sampling in the designated area.

Quality Assurance (QA):

Review sampling records and ensure compliance.

4. Definitions

1. Sampling: The process of selecting a portion of material from a lot for testing and verification.
2. AQL (Acceptable Quality Level): Standard used for sampling quantity.
3. GMP: Good Manufacturing Practices.

5. Materials and Equipment Required

1. Sterile gloves
2. Sampling tools (scoop, forceps, etc.)
3. Clean sampling bags/containers
4. Permanent marker
5. Labels/stickers for identification
6. Disinfectant and cleaning wipes
7. PPE (lab coat, mask, cap, gloves)

6. Procedure
6.1 Preparation for Sampling
Receive Notification:

QC is informed of incoming packing materials by the warehouse/store.

Review Documents:

Verify Delivery Challan, Packing List, and COA (Certificate of Analysis).

Ensure Cleanliness:

Wear proper PPE. Sanitize hands and disinfect tools before sampling.

6.2 Sampling Environment
Conduct sampling in a designated, controlled sampling area (e.g., packing material sampling booth).

Ensure the area is clean and free from contaminants.

6.3 Sampling Quantity
Sample according to approved AQL tables or internal sampling plan, depending on type and quantity of material.

Material Type	Sampling Plan

6.4 Sampling Method
Verify Material Details:

Check the material name, item code, batch/lot number, manufacturer, and quantity.

Open Containers:

Select containers/boxes randomly using a sampling plan.

Collect Samples:

Use clean tools to collect representative samples.

Do not touch the material directly with hands.

Avoid damage or contamination.

Label Samples Properly:

Include: Material name, item code, sample number, batch/lot number, sampling date, sampled by.

Close Containers:

Reseal sampled containers to prevent contamination or damage.

6.5 Handling of Samples
Transfer samples to the QC lab in labeled sample bags/containers.

Store samples under recommended conditions until testing.

6.6 Sampling of Critical Materials
For primary packing materials that come in direct contact with the product, follow stricter aseptic techniques and sampling within classified environments if applicable.

7. Documentation
Record sampling details in the Packing Material Sampling Logbook.

Attach a Sample Slip with each sample sent to QC.

File all documentation with the Batch/Material File.

8. Precautions

•  Avoid contamination during sampling.
• Do not reuse sampling tools without cleaning and sanitization.
• Handle printed materials (labels/leaflets) carefully to avoid mix-ups.

9. References

1. WHO GMP Guidelines
2. Company Quality Manual
3. Approved Material Sampling Plan
4. ISO 2859-1 (Sampling Procedures)

🎓 Discover one of the best Quality Assurance courses available — click below to explore the course that’s shaping future QA skills.

https://trcjw.on-app.in/app/oc/306166/trcjw