Standard Operating Procedure (SOP)

Here is a Standard Operating Procedure (SOP) for the Collection and Storage of Control Samples. This procedure ensures the integrity and traceability of control samples, which are essential for the validation of analytical methods and the monitoring of product consistency.

1. Purpose

The purpose of this SOP is to outline the procedure for the collection, labeling, storage, and disposal of control samples. These samples are collected to serve as a reference for verifying the quality and consistency of production batches and ensuring compliance with established quality standards.

2. Scope

This SOP applies to the collection, labeling, and storage of control samples from all manufacturing processes, including raw materials, intermediate products, and finished products. It applies to both active and reserve control samples.

3. Responsibilities

• Quality Control (QC) Personnel:

  • Collect control samples according to the procedure.

  • Ensure proper labeling, storage, and documentation of control samples.

  • Prepare the control samples for testing and maintain traceability.

• Quality Assurance (QA):

  • Oversee the collection and storage processes to ensure compliance with quality standards.

  • Review and maintain records of control samples for regulatory purposes.

• Warehouse/Store Personnel:

  • Store control samples in appropriate conditions and ensure their availability for future testing.

4. Definitions

• Control Sample: A sample of a product or material that is collected and stored to verify the quality of the product, batch, or manufacturing process.

• Retention Sample: A portion of the product kept for future analysis, usually from the same batch as control samples.

• AQL (Acceptable Quality Level): A sampling standard that defines the maximum acceptable number of defective products in a sample.

• Stability Testing: The process of assessing the stability of a product under defined conditions over a specific period.

5. Materials and Equipment Required

• Clean, labeled sampling containers (vials, jars, etc.)

• Permanent marker for labeling

• Sample collection tools (scoops, forceps, etc.)

• Appropriate storage containers (e.g., refrigerators, freezers, etc.)

• Data sheets or logbook for record-keeping

• Personal Protective Equipment (PPE) (gloves, lab coat, etc.)

• Disinfectants and cleaning materials

6. Procedure

6.1 Collection of Control Samples

1. Determine Sampling Quantity:

   • The quantity of control samples to be collected should be based on internal guidelines, batch size, and regulatory requirements. Generally, a minimum of three samples should be collected:

     • One for routine testing.

     • One for stability testing (if applicable).

     • One for retention, in case further testing or investigations are needed.

2. Preparation:

   • Ensure that all collection equipment is clean and disinfected before use.

   • Wear appropriate PPE (e.g., gloves, lab coat).

   • Verify the batch number, lot number, and manufacturing date of the material to be sampled.

3. Sample Collection Method:

   • For liquid products: Use sterile pipettes or scoops to take a representative sample from different areas (e.g., top, middle, bottom) of the container.

   • For solid products: Use a clean scoop or forceps to collect a representative portion of the material from different locations.

   • For bulk materials: If applicable, mix the material well before taking samples to ensure homogeneity.

4. Labeling of Control Samples:

   • Immediately label each sample with the following information:

     • Material name

     • Batch/lot number

     • Date of collection

     • Sample identifier (e.g., “Control Sample A”)

     • Initials of the person collecting the sample

5. Seal and Package Samples:

   • Seal each sample in a clean, suitable container (e.g., vial, jar, or tube).

   • Ensure that containers are appropriately sealed to avoid contamination or leakage.

6.2 Storage of Control Samples

1. Storage Conditions:

   • Store control samples under the appropriate conditions as specified by the product’s storage requirements (e.g., temperature, humidity, light exposure).

     • Room Temperature: Store products that do not require refrigeration.

     • Refrigeration: Store products requiring temperatures between 2-8°C.

     • Freezing: Store products requiring freezing at -20°C or lower, as necessary.

2. Storage Area:

   • Store control samples in a designated sample storage area such as a QC storage room or refrigerated storage unit. Ensure that the storage area is clean, secure, and properly labeled.

3. Rotation of Samples:

   • Periodically inspect stored samples to ensure that they are in good condition and remain within their specified shelf life.

6.3 Record Keeping and Documentation

1. Control Sample Logbook:

   • Maintain a Control Sample Logbook or electronic record for all control samples. Records should include:

     • Sample identifier

     • Batch/lot number

     • Date of collection

     • Quantity of sample collected

     • Storage location

     • Test results (if applicable)

     • Date of disposal (if applicable)

2. Sample Request Form:

   • Fill out a sample request form or internal tracking sheet to document the specific purpose of the sample (e.g., stability testing, routine analysis).

6.4 Disposal of Control Samples

• Control samples should be retained as per company policy and applicable regulations.

• If a sample is no longer required or has exceeded its retention period, it should be disposed of according to local environmental regulations and documented accordingly.

7. Precautions

• Avoid contamination during the collection process by using sterile equipment and handling samples with clean hands.

• Ensure proper labeling of all control samples immediately after collection.

• Do not use control samples that have been stored improperly or have passed their stability testing limits.

8. Compliance and Auditing

• Compliance with this SOP will be monitored through periodic audits and inspections by QA/QC to ensure that all control samples are collected, labeled, and stored in accordance with the defined requirements.

9. References

• Good Manufacturing Practices (GMP) for the storage and handling of control samples

• ICH Q7 Good Manufacturing Practice for Active Pharmaceutical Ingredients

• FDA Guidance for Industry on Stability Testing of Drug Substances and Products

• Company Quality Manual.

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