Challenges of Clinical Secondary Packaging and Labelling 


Secondary packaging and labelling of clinical trial material present unique challenges due to regulatory requirements, patient safety concerns, and logistical complexities. Navigating these challenges requires a comprehensive understanding of the regulatory landscape, and best practices in packaging and labelling. 

Here are some challenges and considerations in clinical packaging and labelling:  

Regulatory Compliance: Pharmaceutical packaging and labelling must comply with the label text requirements quoted within the regulations enforced by agencies like the EMA (European Medicines Agency) in Europe, MHRA in the UK, FDA (Food and Drug Administration) in the United States and other global regulatory bodies. Keeping up with changing regulations and ensuring compliance throughout the product lifecycle is critical. 

Multinational Country Requirements: To ensure sufficient recruitment in clinical studies, clinical sites are situated in multiple countries. Companies are required to ensure that the local language is used within the country, therefore accurate translations of label text is required.

Packaging and labelling play a crucial role in ensuring patient safety and adherence to dosage instructions. Artwork management, clear instructions, and packaging that protects the product from damage or contamination are essential for patient compliance and safety.  

Supply Chain Complexity: Clinical studies involves managing complex supply chains, including sourcing materials, logistics, distribution, and inventory management. Challenges may arise due to supply chain disruptions, quality control issues, or delays in obtaining necessary packaging materials. 

Sourcing of comparator and auxiliary medicines and ensuring that they are appropriately labelled to meet national requirements can require the use of multiple batches with multiple expiry dates. Managing this inventory and ensuring the clinical sites have in date supplies adds to the challenges in the clinical field. 

Sustainability and Environmental Concerns: Balancing the need for sustainable packaging materials with regulatory requirements and product safety standards is increasingly important. Developing eco-friendly packaging solutions without compromising product integrity poses a significant challenge. 

Ensuring that you have clinical product at the site when required and balancing inventory can become a major issue for Sponsors. Fast turnaround of supplies to ensure continuity of material within the clinical study is a key challenge that Sponsors face. Delays due to scheduling of the packaging and labelling work orders and the review and certification of the batches can lead to frustration within Sponsor organisations.  

PNR uses a Fast Track approach to secondary packaging and labelling, with the team keeping  the Sponsor fully informed of the packaging progress, however complex that might be. Direct access to your assigned QP allows all bulk batch specific queries to be resolved  prior to secondary packaging of your product. Packaging review and certification can run in parallel to the preparation of your product for distribution. 

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