Standard Operating Procedure for Sampling Procedures

1) Purpose

This SOP outlines the procedures for sampling raw materials, intermediates, active pharmaceutical ingredients (APIs), and finished products to ensure that samples are representative and suitable for testing and analysis.

2) Scope

This SOP applies to all sampling activities conducted within the pharmaceutical manufacturing, quality control, and quality assurance departments.

3) Responsibilities

The Quality Control (QC) department or designated sampling personnel are responsible for carrying out sampling activities. Quality Assurance (QA) is responsible for overseeing the process and ensuring compliance with this SOP and regulatory requirements.

4) Procedure

4.1 Preparation for Sampling

1. Review the sampling plan and ensure all necessary materials and equipment are available (e.g., sampling tools, containers, labels, PPE).
2. Verify the cleanliness of sampling tools and containers to prevent contamination.

4.2 Sampling from Raw Materials

1. Ensure the sampling area is clean and sanitized.
2. Open the container carefully to avoid contamination.
3. Use a sampling tool to extract a representative sample from different locations within the container.
4. Place the sample into a clean, labeled container.
5. Seal the sample container and label it with the relevant information (e.g., material name, batch number, sampling date).

4.3 Sampling from Intermediates and APIs

1. Identify the sampling points according to the sampling plan.
2. Use appropriate sampling techniques to ensure the sample is representative of the whole batch.
3. Transfer the sample to a clean, labeled container, ensuring minimal exposure to the environment.
4. Seal and label the sample container as per the requirements.

4.4 Sampling from Finished Products

1. Select units for sampling based on the sampling plan (e.g., random selection, stratified sampling).
2. Open the packaging carefully to avoid contamination and damage.
3. Collect the sample and place it in a clean, labeled container.
4. Seal and label the sample container with all necessary details.

4.5 Sample Handling and Storage

1. Handle samples with care to avoid contamination and degradation.
2. Store samples under conditions specified in the sampling plan or relevant SOPs (e.g., temperature, humidity).
3. Maintain a sample log to record all relevant details, including sample identification, storage conditions, and handling information.

4.6 Documentation

1. Document all sampling activities in the sampling logbook, including the date, time, batch number, sampling location, and any observations.
2. Ensure that all labels and documentation are accurate and complete.
3. Review and approve sampling documentation as required.

5) Abbreviations, if any

SOP: Standard Operating Procedure
QA: Quality Assurance
QC: Quality Control
PPE: Personal Protective Equipment
API: Active Pharmaceutical Ingredient

6) Documents, if any

Sampling Plan, Sampling Logbook, Sample Labels, Sample Storage Records

7) Reference, if any

Regulatory guidelines such as FDA Guidance for Industry: Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, ICH Q6A (Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances)

8) SOP Version

Version 1.0