1. Purpose
The purpose of this Standard Operating Procedure (SOP) is to provide a guideline for the raw material stability testing procedure and its review.
2. Scope
This SOP applies to all raw materials used in the production process.
3. Responsibilities
The Quality Control (QC) department is responsible for conducting the raw material stability testing.
4. Apparatus / Equipment Required
– Balance
– Refrigerator
– Incubator
5. Procedure
5.1 Sample Preparation
– Collect the required raw material samples from the storage area.
– Label each sample with the product name, batch number, and date of collection.
– Record the weight of each sample.
5.2 Stability Testing Procedure
– Place the samples in the refrigerator at a temperature of 5±3°C for long term storage.
– Remove the samples at predetermined time intervals as per the shelf life study.
– Record the appearance, odor, and color of the samples.
– Measure the weight loss of each sample.
– Analyze the samples for any physical or chemical changes, using the relevant analytical methods.
5.3 Stability Indicating Tests (SIT)
– For each raw material, the QC department must conduct the Stability Indicating Test (SIT) to evaluate potential degradation products and impurities in the sample.
– Analyze the samples for any impurities or degradation products, using the relevant analytical methods.
6. Documentation
– Record the sample preparation, testing results, and observations as per the SOP.
– Document all stability test results and compare the test results with the specifications provided.
7. Reporting and Review
– QC department is responsible for reporting and reviewing the results of the raw material stability testing.
– Record and maintain all raw material stability testing documentation.
– Notify the relevant departments if any issues arise in the raw material stability testing.
8. Frequency
– Conduct raw material stability testing as per the frequency specified in the stability protocol / shelf life study.
9. Storage
– Store the raw material samples in accordance with their specifications.
– Record the storage conditions of the samples.
10. Reducing variability due to environmental conditions
– Keep the samples in a stable temperature and humidity environment before, during and after sample taking.
– Isolate the samples from each other.
Note: SOPs may vary depending on the organization’s requirements and the type of raw materials used. It is crucial to adapt the SOP to the organization’s specific needs.
