Embrace Packaging And Delivery Systems Designed For Today’s Standards
By Fran DeGrazio, executive editor
![]()
Pharmaceutical companies love to tout innovation but don’t always implement actual change. This is particularly true when it comes to innovation or change in their approaches to sterile packaging, delivery systems, or, ultimately, combination products comprising various components and constituent parts. The tendency is to stick with what has worked in the past. Doing so can seem to minimize risk and maximize efficiency. But does it?
Pharmaceutical companies often fail to recognize the hidden or looming downsides of product development stasis: unexpected costs, loss of resources to areas of low value, and negative impacts to drug quality and compliance. Frankly, all of these can — and likely will — result from falling back on how things have always been done rather than implementing best practices for the future.
Resistance To The New Is Not New
Let’s look at the day-to-day reality of what commonly happens when a pharmaceutical company is choosing, for example, the packaging components or delivery system for an injectable drug product, such as a prefillable syringe. Quite often, the company will choose components or systems it has previously used, believing it is minimizing risk regarding suitability factors it must consider: compatibility, performance, protection, and safety. Choosing a previously used component leverages prior analytical work and provides a reassuring degree of familiarity from a technical and regulatory standpoint. The choice may also leverage long-established and company-friendly pricing.
The company can also face considerable resistance when asking the manufacturer of the product (internal or outsourced) to move on from a component or system it has used for years. Anything new can bring challenges and unknowns into the processing arena, sometimes contributing to manufacturing inefficiencies until issues are addressed.
Moreover, under the guise of continuous improvement, pharma companies can spend tremendous amounts of time and energy engaging suppliers to overcontrol the product they are using rather than choosing a component or system that has been more recently developed to meet the current needs of the industry. While continuous improvement should be an overall part of any product’s lifecycle, it cannot magically change the core nature of an older product and its original characteristics and intent.
Old Products Introduce New Risks
As much as using familiar products can provide a certain level of comfort, the practice can also — and usually will, over time — generate new risks. Perhaps the most concerning is the potentially poor fit between, on the one hand, old products and, on the other, new and evolving regulations. When the fit is poor, the cost of compliance can skyrocket — if companies can even achieve compliance using an older product.
Pharma companies that use, for example, packaging components developed many years ago may do so because they believe (or hope) that the products are good enough to remain acceptable in today’s quality and regulatory environment even though these products may have been originally qualified more than 30 years ago. When a company uses such components on a consistent basis, however, it may discover that the product is too variable or lacks certain quality characteristics. In that common scenario, a pharma company that is unwilling to switch to a new, more recently developed product will ultimately put an incredible amount of time, effort, and resources into trying to “force fit” a product that was not designed to meet current standards. Many of these regulations could not have been imagined or anticipated when the product was originally created.
Continue Reading…
Pharmaceutical companies love to tout innovation but don’t always implement actual change. This is particularly true when it comes to innovation or change in their approaches to sterile packaging, delivery systems, or, ultimately, combination products comprising various components and constituent parts. The tendency is to stick with what has worked in the past. Doing so can seem to minimize risk and maximize efficiency. But does it?