Shelf Life of Pharmaceuticals: Ensuring Safety and Efficacy

Shelf Life of Pharmaceuticals: Ensuring Safety and Efficacy
May 29, 2024 Macklin Tan
In Article
shelf life

In the world of pharmaceutical manufacturing, shelf life or best before date is a term that explains when the product is still good to use. This guideline is especially important for consumable products such as medicines and other pharmaceutical products. 

It is important information that will help customers understand how long the products are still safe to consume. This can prevent dangerous risks that may occur due to significant chemical or physical changes in the product. 

This article will explore the meaning of this term in a product, the factors influencing it, and why it is important in a product.

What is Shelf Life?

This is the period during which the product remains safe to use, effective, and maintains its good quality when stored in specific conditions. This is commonly associated with perishable goods such as food, pharmaceuticals, and cosmetics. In pharmaceuticals, shelf life is determined through stability testing conducted by pharmaceutical manufacturers.

Pharmaceutical products may change in appearance, consistency, content uniformity, clarity, moisture contents, and many more. These changes can affect the product’s safety and efficiency. Therefore, stability testing is conducted regularly to determine how long the products stay in their original appearance or consistency when stored correctly.

Factors Influencing Shelf Life

The length can be different depending on the type of medication, formulation, packaging, storage conditions, and the chemical composition. These are three factors that can influence the longevity of pharmaceutical products.

Chemical Composition

Pharmaceutical products often contain active pharmaceutical ingredients that may degrade over time. This can lead to loss of potency and could even be harmful when consumed. Fillers, binders, and preservatives will impact the stability of pharmaceutical products which affects longevity.

Storage Condition

It is important to store pharmaceutical products properly to ensure their longevity. Light, humidity, and temperature exposure can accelerate the degradation process, making pharmaceutical products easily go bad after prolonged exposure. The recommended storage conditions are cool and dry places away from direct sunlight and moisture. 

Packaging

Packaging serves to protect products from various external factors that can degrade the formulation of the products. That is why materials and design can also significantly impact the longevity of pharmaceutical products.

Additionally, proper selling and closure mechanisms are also important to prevent contamination and maintain product integrity.

Why is Shelf Life Important?

It is important because customers can maximize its use before it changes appearance and consistency which can be harmful to use. Here are five reasons why this is important.

Consumer Safety

This date indicates the period during which a product is expected to remain safe for consumption. Adhering to this guideline helps prevent consumers from consuming products that may have degraded, reducing the risk of adverse health effects that may occur.

Product Efficacy

Over time, pharmaceutical products may lose their potency or effectiveness due to the degradation of active ingredients or other components. Adhering to shelf life ensures that the products maintain the intended therapeutic or functional effects. 

Quality Assurance

For pharmaceutical companies, this guideline is essential for customer satisfaction and brand reputation. Adhering to this best-before date will ensure the product consistently meets quality standards which enhances customer trust and loyalty. Customers trust companies that strictly adhere to the regulations enforced by the authorities.

Regulatory Compliance

The government enforces guidelines and requirements for manufacturers to establish best-before date based on stability testing and other factors. They need to comply with these regulations as it is important for legal and ethical reasons.

Complying with this regulation demonstrates the companies’ commitment to consumer safety, quality assurance, and transparency.

Minimizing Waste

This guideline can also help minimize product waste as there is clear guidance on when to use or consume pharmaceutical products before they expire. This reduces the possibility of products being discarded prematurely due to concerns about safety or quality. Therefore, this best-before date also helps minimize waste.

Ensuring Safety and Efficacy

Best before date plays an important role in ensuring the safety and efficacy of pharmaceutical products. These products directly impact patient health and well-being. Therefore even small changes can increase adverse health effects.

Rigorous testing and quality control measures are implemented during the drug development and manufacturing process to ensure its safety and efficacy. One of the important methods to ensure safety is through compliance with the Good Manufacturing Practices or GMP.

GMP governs every aspect of pharmaceutical production from raw material sourcing to final product distribution. They provide strict requirements for facility cleanliness, equipment calibration, personnel training, and documentation practices. These efforts are all aimed at minimizing the risk of contamination and ensuring product consistency.

Additionally, regulatory authorities such as the FDA and EMA enforce strict regulations to evaluate and approve pharmaceutical products before they reach the market. These authorities review comprehensive data on drug safety, efficacy, and quality obtained from preclinical studies, clinical trials, and manufacturing processes. 

Through robust assessment procedures, the authorities verify compliance with established standards and guidelines. Complying with these guidelines and requirements means the company upholds the integrity of its products. It helps companies improve their confidence in the safety and efficacy of the medication they produce.

In conclusion, understanding and managing the best-before-date of pharmaceutical products is crucial for ensuring their safety, efficacy, and quality throughout their lifecycle. By adhering to rigorous manufacturing standards, conducting comprehensive stability studies, and implementing proper storage and handling practices, companies can prolong the best-before date of their products.

For small manufacturers, Linx offers a powerful expiry date printer. You are recommended to read about: The Primacy of Powerful Expiry Date Printer from Linx to understand more about its features and why you should choose this printer. 

There are plenty of great printers to use for your manufacturing company. However, to get the right one to print the shelf life date, batch code, or other important information for your product, you need to read about: Know These 4 Things Before You Buy a Batch Code Printer. You can also see a complete list of continuous inkjet printers here.

References

https://eprints.ugd.edu.mk/19275/3/7.%20STABILITY%20AND%20SHELF%20LIFE.pdf 

https://www.fda.gov/drugs/pharmaceutical-quality-resources/expiration-dates-questions-and-answers#:~:text=Why%20are%20expiration%20dates%20important,to%20its%20labeled%20storage%20conditions

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3429690/ 

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