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What are the common challenges and pitfalls in shelf life estimation and validation?

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Shelf life estimation and validation are crucial steps in the development and manufacturing of pharmaceutical products. They ensure that the products meet the quality, safety, and efficacy standards throughout their intended storage and use. However, there are many challenges and pitfalls that can affect the accuracy and reliability of shelf life estimation and validation. In this article, we will discuss some of the common ones and how to avoid or overcome them.

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1 Regulatory requirements

One of the main challenges in shelf life estimation and validation is to comply with the regulatory requirements of different markets and regions. Different authorities may have different definitions, criteria, methods, and standards for shelf life estimation and validation. For example, the US Food and Drug Administration (FDA) requires accelerated stability testing, while the European Medicines Agency (EMA) prefers real-time stability testing. Therefore, you need to be aware of the specific requirements of each market and region, and follow the appropriate guidelines and protocols.

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2 Stability testing

Another challenge in shelf life estimation and validation is to design and conduct adequate and robust stability testing. Stability testing is the process of exposing the product to various environmental conditions, such as temperature, humidity, light, and oxygen, and measuring the changes in its physical, chemical, microbiological, and biological properties over time. Stability testing can be done in real-time or accelerated conditions, depending on the product characteristics and regulatory requirements. However, stability testing can be complex, time-consuming, costly, and prone to errors and uncertainties. You need to consider factors such as sample size, sampling frequency, test methods, analytical techniques, data analysis, and extrapolation methods.

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May Meng

Expert in medical device and combination products.
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I would also add in-use stability testing. The stability related regulatory standards could be added for guidance. Transportation conditions could also affect stability of the drug.

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Robin Best

Quality Manager participating in Qualified Person training modules, looking for a sponsor, and Experienced Quality Professional in the Pharmaceutical Industry
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I would also add a consideration to the way the product is stored in the chambers, especially for liquid based presentations. Do you store them all upright, on their side or inverted the latter two orientations would ensure that the product is in contact with the container closure during the study where this contact could lead to unexpected results.

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3 Accelerated aging

One of the common pitfalls in shelf life estimation and validation is to rely too much on accelerated aging. Accelerated aging is the process of applying higher stress conditions to the product to simulate the effects of long-term storage in a shorter time. Accelerated aging can be useful to predict the shelf life of the product when real-time testing is not feasible or practical. However, accelerated aging has limitations and assumptions that may not reflect the actual behavior of the product under normal storage conditions. For example, accelerated aging may not account for non-linear degradation, synergistic effects, or threshold effects. Therefore, you need to validate the accelerated aging model and assumptions, and supplement it with real-time testing whenever possible.

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Fathima Doole

Membrane Biophysicist | Analytical Method Development | Dissolution Scientist
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Consider a drug whose efficacy degrades not just with time, but also due to interactions with trace elements in its packaging, a factor which might only manifest over longer periods. This will not be taken into account in linear degradation studies.

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4 Product variability

Another pitfall in shelf life estimation and validation is to ignore or underestimate the product variability. Product variability refers to the differences in the product quality and performance due to factors such as manufacturing processes, raw materials, packaging materials, storage conditions, and handling practices. Product variability can affect the stability and shelf life of the product, and introduce uncertainties and errors in the estimation and validation. Therefore, you need to control and monitor the sources of product variability, and use appropriate statistical methods and tools to analyze and account for the variability in the data.

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5 Labeling and storage

A final challenge in shelf life estimation and validation is to ensure that the labeling and storage of the product are consistent with the shelf life claim. Labeling and storage are important aspects of good manufacturing practice (GMP) that inform and guide the users and consumers of the product. The label should clearly indicate the shelf life of the product, as well as the storage conditions and instructions. The storage should ensure that the product is protected from adverse environmental factors, such as temperature, humidity, light, and oxygen. However, labeling and storage can be challenging due to factors such as market preferences, distribution channels, logistics, and compliance. Therefore, you need to consider the labeling and storage requirements and implications of each market and region, and ensure that they are aligned with the shelf life estimation and validation.

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Fathima Doole

Membrane Biophysicist | Analytical Method Development | Dissolution Scientist
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As per my knowledge for food products, the "Best Use By" or "Best Before" date is commonly used to indicate when the product will maintain optimal quality. For products where safety is a concern after a certain period, like medications or some perishable foods, the "Expiry Date" should be clearly labeled. Additional information like production or packaging date can also be helpful for consumers. While "Shelf Life" is an overall estimation of product longevity, the "Best Use By" date denotes optimal quality, and the "Expiry Date" indicates safety limits.

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6 Here’s what else to consider

This is a space to share examples, stories, or insights that don’t fit into any of the previous sections. What else would you like to add?

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What are the common challenges and pitfalls in shelf life estimation and validation?

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1 Regulatory requirements

2 Stability testing

3 Accelerated aging

4 Product variability

5 Labeling and storage

6 Here’s what else to consider

GMP

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