Standard Operating Procedure (SOP)

1. Purpose

This SOP defines the procedure for proper collection, labeling, and storage of retained samples of raw materials to ensure compliance with regulatory and quality requirements.

2. Scope

This procedure applies to all raw materials received and sampled in [Organization/Department Name] for manufacturing or laboratory testing purposes.

3. Definitions

• Retained Sample: A representative sample of a raw material batch kept for future reference, investigation, or stability assessment.

• Raw Material: Any unprocessed material used to manufacture products.

• Sampling: The process of selecting a portion of material to represent the whole batch.

4. Responsibilities

• Quality Control (QC) Personnel: Collect and label retained samples properly and ensure accurate documentation.

• Warehouse/Store Staff: Provide assistance in storage according to specified conditions.

• Quality Assurance (QA): Periodically review storage conditions and ensure compliance with retention policies.

5. Materials and Equipment

• Clean, dry sampling containers (airtight and inert)

• Sampling tools (e.g., scoops, spatulas)

• Labels and markers

• Retained sample logbook or electronic system

• Storage racks, desiccators, refrigerators (if required)

• Personal Protective Equipment (PPE)

6. Procedure

6.1 Collection of Retained Samples

• Collect retained samples during initial sampling of raw material at the time of receipt inspection.

• Use clean and dedicated sampling tools to avoid contamination.

• The quantity of retained samples should be sufficient to perform at least two full analyses.

• For each batch of raw material, collect one retained sample.

6.2 Labeling of Retained Samples

Each retained sample container must be labeled with:

• Material name

• Material code or ID

• Batch or lot number

• Supplier name

• Date of sampling

• Expiry date (if applicable)

• Storage conditions (if specific)

6.3 Storage of Retained Samples

• Store retained samples under conditions that best preserve their integrity (e.g., controlled temperature, humidity, protection from light).

• Place the samples on designated racks or in specific cabinets labeled “Retained Samples.”

• For hygroscopic or temperature-sensitive materials, use desiccators or refrigerators as required.

• Segregate materials to avoid cross-contamination.

6.4 Retention Period

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

• For raw materials not used in product manufacture, retain samples for a minimum of three years from the date of receipt or as per internal policies.

6.5 Disposal of Retained Samples

• Review retained samples periodically for expiry.

• Dispose of expired or unused retained samples as per the approved waste disposal procedures.

• Document the disposal activity with date, batch details, quantity, and method of disposal.

7. Documentation

• Record the details of each retained sample in a retained sample logbook or an electronic database, including date of collection, batch number, and storage location.

• Maintain a tracking system for easy retrieval during audits or investigations.

• Record environmental monitoring data for storage areas as applicable.

8. Precautions

• Always use PPE during sampling and handling.

• Prevent contamination by using clean sampling tools and containers.

• Ensure proper labeling immediately after sample collection.

• Store flammable or hazardous raw materials in compliance with safety regulations.

9. References

• GMP (Good Manufacturing Practices) Guidelines

• ICH Q7: Good Manufacturing Practice for Active Pharmaceutical Ingredients

• Internal Quality Manuals and Policies.

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