You might be familiar with pharma track and trace programs that have become common place in the pharmaceutical industry. Track and trace, or “pharmaceutical serialisation” as it is also called, is the process of documenting the production, packaging and handling, and distribution process of a drug, to ensure that it is safe for consumption. Pharma serialisation helps ensure that the medications have been created in safe conditions, that they are distributed within the established shelf life guidelines, and that there is end-to-end accountability to prevent tampering or theft of drugs.
One big piece of this puzzle is the stability studies that establish the shelf life. The shelf life of any given medical substance is a huge piece in the safety and health of the pharmaceutical industry. Stability studies determine how the drug will react in various conditions, with a variety of packaging types, and how long it is safe and effective for consumption. We’ve outlined common questions about stability studies below.
Frequently Asked Questions for Pharma Stability Studies
- What are stability studies?
Stability studies evaluate what a drug does in various temperatures or humidity factors. This usually involves storing the drug that is undergoing the stability studies in temperatures of more than 100 degrees, and then in temperatures less than 70 degrees, and then in environments that have greater than 75% humidity. They may also be tested in several different packaging forms, so that a comparison can be made and the ideal packaging determined. The way that the drug handles the extreme conditions is documented and used to determine the shelf life guidelines.
- Why are stability studies so important?
Every medication that the FDA approves for public use is different. Each medication has its own way of reacting in certain circumstances, some of which make them ineffective, or even harmful, for consumption. The stability studies are a consistent way to ensure that any specific guidelines for the drug’s use are identified before it hits the market. Without stability studies, there would be a huge gap in the way drugs are tested, which could create health and safety vulnerabilities.
- How does the stability studies impact a drug’s shelf life?
During the stability studies, the drug will be monitored in its proposed packaging in the “normal conditions” (approximately 77 degrees Fahrenheit and 60% humidity) for a certain length of time to determine the product’s expiration date. If the product deteriorates before the pre-determined time-frame, scientists know that the expiration date should be changed before it hits the market.
- Won’t the stability studies be thrown off if the particular unit behaves unlike the rest of the batches or lots?
Great question. To ensure that their is no discrepancy with a particular batch that throws off all of the study results, stability studies usually involve samples from at least three lots. Ideally, all three lots should respond to the stability studies similarly. If there is any variation in the results from the stability studies in one particular batch, the scientists performing the tests understand that they need to broaden their study samples.
Depending on the nature of the medication being tested, the study directors might need more than three lot samples to begin with, but that is the general guideline.
- How is the quality of the product tested after the pre-determined time-frame?
Unless otherwise determined, the product is tested every three months for two years, to evaluate how it holds up over time. The exact methods of testing depends on the nature of the drug being tested, but often answers the following questions:
- Has the color of the product changed over time?
- Is the appearance any different than it was at the previous interval?
- Does the product smell different?
- Is the product more likely to crumble, chip, or fall apart than it was at the previous interval?
- Has the potency of the active substances in the product changed?
- Are there any impurities in the product?
- Has the product disintegrated or dissolved since the previous interval?
- What is the water content of the product and how has it changed over time?
The answers to these questions help determine the quality of the product, which helps determine the shelf life over time.
Do you have any other questions about stability testing? Please share in the comment section below!