3. November 2014
In recent years, packaging errors have become a common cause of drug recalls, forcing the U.S. Food and Drug Administration (FDA) to introduce tighter regulations to ensure patient safety. The wrong packaging can render a drug unusable or potentially dangerous and can entangle pharmaceutical manufacturers in damaging compliance issues. The reason is that a drug tends to interact with the container over the course of time. Even primary packaging that has been manufactured and stored properly can release substances into the formulation. In the worst case, this harms the integrity of the drug, and it has to be withdrawn from the market.
In 2010 alone, the FDA pulled nine different drug products from the market after glass flakes were discovered in the drug — a result of glass delamination, which is the detachment of thin layers of glass from the inner surface of glass containers. In the wake of the 2010 packaging recalls, the FDA sent out a warning letter to the pharmaceutical industry and now expects them to assess the delamination risk of each drug and container combination. For drugs with moderate to severe delamination risks, companies must run detailed tests to ensure shelf life stability and comply with federal regulations.
Assessing the amount and toxicity of leachables from primary packaging is another type of testing that will become increasingly required. Recent guidelines for metal-ion leachables from glass packaging will be implemented in 2015, resulting in leachable standardization. Additional best-practice guidelines have been given to help assess leachables from drug product and container packaging interactions. These types of tests are best conducted by analytical testing laboratories, like SCHOTT pharma services, that have experience with raw material specifications, material manufacturing, and drug product and container interactions.
In response to these packaging recalls and new guidelines, the pharmaceutical industry is starting to change its views on pharmaceutical packaging. Companies previously selected suppliers based on price, since the container was seen as more of a commodity item. In recent years, however, packaging has become an integral part of the overall product concept, and more manufacturers are treating suppliers as partners. Now more pharmaceutical manufactures believe that choosing the right packaging partner has a major impact on drug success.
But when is the best time for a pharmaceutical company to approach a packaging supplier? By participating in development projects from the very beginning, packaging experts can contribute their unique know-how at an early stage. From the packaging manufacturer’s point of view, partnering more closely with pharmaceutical companies enables them to gain an even deeper understanding of their customers’ business needs.
A good example of this “open innovation” approach is the Supplier Relationship Center (SRC) for Roche/Genentech Pharmaceuticals. Roche founded this center to help drive innovation by working closely with key suppliers. SCHOTT was one of the partners selected for the pilot phase of this project, exclusively representing the area of glass packaging. This collaboration goes well beyond pure packaging, and also takes business processes into account. This helps to advance packaging concepts and services even further.
Companies that run such an integrated approach might have to spend more upfront when implementing packaging solutions, but this choice reduces overall costs and increases the safety for patients in the end. Ultimately, with SCHOTT’s product developers working closely with the subject matter experts from pharmaceutical companies, manufacturers have the right partner at their side to support them in finding the best packaging solution for their drug.