1. Purpose
The purpose of this standard operating procedure (SOP) is to provide guidance on the raw material sampling plan procedure. This SOP outlines the process of sampling and testing raw materials to ensure they meet the required quality standards for use in the manufacturing process.
2. Scope
This SOP applies to all staff involved in the raw materials sampling process.
3. Responsibilities
The following personnel are responsible for ensuring compliance with this SOP:
– Production Manager
– Quality Control Manager
– Laboratory Technician
– Raw Material Warehouse Supervisor
4. Materials Required
– Sampling equipment (such as scoops, spoons, or pipettes)
– Labels
– Marker pens
5. Sampling Process
5.1. Sample Size
– The size of the sample taken should be large enough to be representative of the entire lot.
– The recommended sample size as per regulatory guidelines is at least 5% of the lot size.
– The minimum sample size should be 200 grams.
Number of containers to be sampled is as follows:
For containers upto 5 : All containers.
For containers above 5: √n +15
.2. Sampling Procedure
– The Sampling procedure should be conducted only by trained personnel who follow proper hygiene procedures.
– The samples should be taken from at least 10 different points in the lot, at various depths, and locations, in a random manner.
– The samples should be taken from different containers or sacks from the lot.
– The samples should be taken from the middle of the lot avoiding the top or bottom layer where separation can occur.
5.3. Sample labeling and documentation
– Samples should be labeled with the lot number, date of sampling, name of the sampler, Sampling point identification number.
– The labeling should be precise, clear, and durable enough for the entire sampling and testing process.
– Samples should be documented with the relevant data such as name of the supplier, date of receipt, expiry date, Certificate of Analysis (COA) of the raw material.
5.4. Transport and Storage of Samples
-The samples should be transported to the laboratory for testing as soon as possible to avoid any deterioration.
– The samples should be kept in well-labeled sample containers and tightly sealed, and stored away from direct sunlight, moisture, and extremes of temperature.
– Samples should be stored at the recommended temperature and duration as per SOP.
6. Conclusion
By following this Raw Material Sampling Plan Procedure SOP, the organization can ensure consistent and reliable quality of raw materials for manufacturing and provide assurance to customers that they are receiving safe and compliant products.