Standard Operating Procedure (SOP)

1. Purpose

To define the procedure for the proper collection, labeling, storage, and maintenance of retained samples of packaging materials to ensure their availability for reference, investigation, and compliance purposes.

2. Scope

This SOP applies to all primary, secondary, and tertiary packaging materials received and used in [Organization/Department Name].

3. Definitions

• Retained Sample: A representative sample of packaging material kept after receipt and/or usage for future reference, analysis, or investigation.

• Primary Packaging Material: Material that directly contacts the product (e.g., bottles, blisters).

• Secondary Packaging Material: Material that encloses the primary container (e.g., cartons).

• Tertiary Packaging Material: Material used for bulk handling and transport (e.g., shipping boxes).

4. Responsibilities

• Quality Control (QC) Department: Collect and store retained samples as per this SOP.

• Warehouse/Stores: Notify QC upon receipt of packaging materials.

• Quality Assurance (QA): Review and audit the retention process.

• Personnel Handling Packaging Materials: Ensure traceability and avoid contamination or mix-up.

5. Materials and Equipment

• Clean sample containers/bags

• Labels and permanent markers

• Storage cabinets/racks

• Logbooks or electronic inventory system

• PPE (Personal Protective Equipment)

6. Procedure

6.1 Collection of Retained Samples

• Upon receipt of each consignment of packaging material, QC personnel shall collect representative samples.

• Sample quantity:

  • Primary packaging: Sufficient for complete evaluation and identification.

  • Secondary and tertiary packaging: Adequate quantity to evaluate printing and construction quality.

• Ensure samples are collected from different points of the consignment (beginning, middle, end) to ensure representativeness.

6.2 Labeling of Retained Samples

Each retained sample must be properly labeled with:

• Material name

• Material code

• Manufacturer’s name and address

• Batch/Lot number

• Receipt date

• Reference number (if applicable)

• Storage conditions (if applicable)

6.3 Storage of Retained Samples

• Store retained samples in a designated, clean, and secure area with controlled access.

• Organize samples in a manner that prevents damage, mix-up, or deterioration.

• Store samples under conditions recommended by the manufacturer or suitable for the material type (e.g., temperature, humidity).

• Arrange samples by material type and receipt date for easy retrieval.

6.4 Retention Period

• Retain samples for at least one year after the expiration date of the finished product using the packaging material or as per regulatory requirements.

• If the packaging material is used for multiple products, the sample shall be retained until the expiration date of the last batch packed with that material.

6.5 Disposal of Retained Samples

• After the retention period expires, dispose of samples as per the disposal SOP.

• Document disposal details including material name, lot number, quantity, date of disposal, and authorization.

7. Documentation

• Record all sample collection, labeling, storage, and disposal activities in the Retained Samples Logbook or electronic system.

• Maintain a cross-reference to the finished product batch records for traceability.

8. Precautions

• Handle samples carefully to prevent damage or contamination.

• Maintain an orderly and systematic storage system.

• Regularly inspect stored samples for signs of degradation.

• Limit access to authorized personnel only.

9. References

• Good Manufacturing Practice (GMP) Guidelines

• ISO 9001 Standards

• Internal Quality Manuals

• Regulatory authority guidelines (e.g., FDA, EMA)

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