1. Purpose:
To ensure accurate and representative sampling of raw materials used in the manufacturing process.
2. Scope:
This procedure applies to all raw materials received for use in the manufacturing process.
3. Responsibilities:
The quality control department is responsible for implementing and ensuring compliance with this procedure.
4. Materials and Equipment:
– Sampling tools (clean and sterilized scissors, forceps, spoons, spatulas, or scoops)
– Clean and sterilized sampling containers (e.g., plastic bags, bottles, or cups) with labels
– Disposable gloves and masks
– Alcohol or disinfectant solution
– Sampling log or record sheet
5. Procedure:
Step 1: Pre-sampling preparation
– Review the supplier’s Certificate of Analysis (COA) or specifications to determine the appropriate sampling plan.
– Verify that the raw materials have been stored under proper conditions, including temperature, humidity, and light exposure.
– Sterilize or clean all sampling tools, containers, and equipment before use.
– Wear clean disposable gloves and masks during the sampling process.
Step 2: Sampling
– Collect a representative sample of the raw material from the container or bag by using a random sampling technique. The size of the sample should follow the sampling plan requirements.
– Collect the sample from different locations of the bulk container or pallet, avoiding the edges and top layer.
– Ensure that the sample is homogeneous, without any visible signs of contamination, damage, or change in appearance, such as clumps or discoloration.
– Transfer the sample to a clean and sterilized sampling container, close the container tightly, and label it with the identification number or name of the raw material, the lot number, the date of sampling, and the sampler’s initials.
– Record the details of the sampling process, including the sampling date, location, method, quantity, and any observations or deviations, in the sampling log or record sheet.
Step 3: Post-sampling activities
– Seal the original container of the raw material and label it with the identification number or name, the lot number, the date of receipt, and the supplier’s name and address.
– Store the raw material and the sampling container under appropriate conditions according to the supplier’s instructions and the company’s procedures.
– Submit the sampling container to the quality control laboratory for testing and analysis, following the standard operating procedures (SOPs) for testing and analysis.
– Dispose of the used gloves and masks and clean or sterilize the sampling tools and equipment after use.
6. Revision History:
This SOP is subject to revision as necessary, and any changes will be documented and communicated to all concerned parties.