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