Fuelled by the expanding global healthcare industry, increasingly ageing populations and advances in available treatments, the pharmaceutical packaging market has seen substantial growth.
This has been reflected in the market value, which is projected to increase from $135.2 billion in 2023 to $284 billion in 2032 at a compound annual growth rate of 7.72%.1
Companies need to stay informed about evolving packaging regulations and adopt best practices to maintain compliance and protect patients; yet, the complexity of the rules and guidelines makes it inherently difficult to navigate this space. Regulatory challenges span various aspects of pharmaceutical packaging.
- Sufficient supply of materials: shortages of materials may mean that alternative suppliers or sources have to be found. Companies have to ensure that they have the necessary qualification expertise and are validated to facilitate obtaining regulatory approvals.
- Accurate information and labelling, changes to packaging and QP release responsibility: companies have to proactively respond to required artwork changes and have the ability to consume the remaining stock. Regulatory authorities require the Qualified Person (QP) release to be done within a certain approved window. This task is often outsourced to packaging partners who take responsibility for QP release for the entire upstream processing chain.
- Automation and AI issues: cost-efficiency requirements mean that companies are increasingly turning to advanced technologies, such as robotics, automation and artificial intelligence (AI). However, the pharmaceutical industry is still in the process of figuring out how best to use AI at various stages of the development, manufacturing and distribution process, with many unknowns and best practices yet to be developed.
- Sustainability considerations: changes to material quality may be triggered by environmental, social and governance (ESG) requirements, resulting in the necessary packaging qualification or regulatory change required (for example, changes to packaging dimensions to reduce material consumption).
Strategies to successfully navigate pharma packaging regulatory hurdles
By adopting a proactive approach to addressing these challenges, companies can effectively navigate the complex regulatory landscape of pharmaceutical packaging.
Engaging with packaging specialists, such as contract packaging organisations (CPOs) with in-depth knowledge of this landscape, helps companies to navigate complex regulations, identify potential pitfalls and ensure compliance.
Strategies that help to ensure compliance and risk mitigation to enhance patient safety and build trust with customers include the following.
- Planning, communication and collaboration: setting detailed plans early in the process and aligning the expectations and responsibilities of all stakeholders, including the customer and CPO, is crucial to remaining compliant with regulatory requirements.
- Investing in innovative solutions: advanced serialisation and track-and-trace technologies — such as smart labels containing radio-frequency identification (RFID) or near-field communication (NFC) technology — help companies to enhance supply chain visibility and follow regulations designed to prevent counterfeiting. The packaging of medications requiring complex delivery routes, such as prefilled syringes for sterile injectables, will likely see more use of smart labels in the near future.
- Staying informed: in the constantly evolving regulatory landscape, continuous monitoring of updates and changes to relevant regulations is essential to stay ahead. Subscribing to industry publications and attending conferences helps companies to stay ahead of regulatory changes.
Regulatory compliance is an ongoing process that requires continuous vigilance and adaptation to changing requirements.
By staying informed, investing in expertise and prioritising patient safety, pharmaceutical companies can successfully navigate regulatory challenges and ensure that their packaging solutions meet the highest standards of quality and compliance.
Reference
- https://www.custommarketinsights.com/report/pharmaceutical-packaging-market/.