Written by Modality Solutions
Posted on: September 5, 2017
Different people have different expectations while developing a drug product shipping solution – for some keeping the final cost low is the most important factor, others measure success by the capability of a shipping solution to keep the drug products within the desired temperature range for the entire expected duration of shipment. Most ask for both!
Defining user requirements is a specification document is an important first step to ensure that everyone involved in a project is working towards achieving the same goal. The packaging is designed and qualified deliver life saving drugs using are variety of modes – air, ground, and even ocean transport – to maintain the safety, quality and effectiveness of the product. User Requirements Specifications (URS) help translate your needs into quantitative and qualitative attributes of a shipping solution that must be met in order to meet the regulatory standards associated with shipping and distribution of drug products. Laying out these requirements upfront also helps customers better understand their own needs and bridge the gaps in their specifications for shipping a product. A few common requirements that must be defined while developing insulated shipping solutions include:
- Acceptable product temperature range,
- Allowable thermal exposures based on product stability data,
- Duration for which the shipping solution is expected to hold the product,
- Thermal profile against which the shipper will be tested, and
- Minimum and maximum payload dimensions and the cost of the solution.
It is also important to specify any special constraints that the shipper might be subjected, such as keeping product in a specific orientation and rough physical handling, at the beginning of the project. Keeping the expected date of delivery in mind is also recommended. Taking the time to accurately state and discuss the user requirements not only helps design an effective solution but helps also reduce the cycle time. Too often the design and qualification of a shipper is hampered by poor definition of true user requirements in the beginning of the project. Changes in specifications, additional requirements, and sometimes competing priorities increase shipper cost and design time needlessly.
It is not always possible to meet all user requirements – in such cases, prioritizing becomes crucial. One way of doing this is by classifying the requirements as “high”, “medium” and “low” and working on achieving them in order of decreasing priority. As a project progresses, any changes in the scope of the expected shipping solution should be recorded with corresponding changes in the user requirements. The final solution can be compared against the user requirements to evaluate its effectiveness in delivering what the customer demanded. User requirements guide the development of a cost-effective and regulatory compliant solution from start to the end.