The concept of Quality by Design is based on the understanding that product quality is primarily dependant on its design. Final product testing alone cannot ensure product quality, quality must be designed into the product. As such regulators now encourage QbD principles to be implemented during both drug product development and manufacturing to ensure the performance and quality of the final drug product is as expected.
The advantages of Quality by Design benefit both the consumer (since the end product will be consistent) and the manufacturer (since quality, costs and timescales will be better understood, controllable and predictable).
Gamlen data means you can make informed decisions, not best estimates.
How important is compaction data in Quality by Design?
Compaction analysis in QbD
To Gamlen, Quality by Design means understanding the compaction behaviour of your tableting materials in order to develop high quality, robust formulations by design, and not by accident.
Having a well optimised formulation from the start of manufacture prevents future tablet failures. Generating compaction data during the development phase will allow you to predict how a formulation will perform during full scale manufacture. This enables you to avoid multiple common tableting problems such as low tablet hardness, high friability, sticking and picking, poor dissolution, capping or lamination issues.
Gamlen data means you can make informed decisions, not best estimates
Absolutely. With Gamlen compaction data you can troubleshoot faster, which means less downtime, less cost, and less waste. You are able to quickly narrow down potential causes of problems in production, with accurate data that will either rule out material factors as the cause or identify which material is causing the problem.
By providing the knowledge you need to prevent problems reoccurring, Quality by Design in compaction data means you can avoid multiple different and familiar problems, such as low tablet hardness, failing friability (chipping) or hardness, sticking and picking, failure on dissolution, and capping or lamination issues.
All of which ensures that your teams save time investigating problems or carrying out root cause analysis, while avoiding halting production or slowing down the tablet press speed.
The benefits outweigh the barriers
Barriers & Benefits
Despite the benefits, implementing QbD principles within a company can create challenges. Typical barriers include the cost of purchasing new equipment, the time and cost required for training, and a lack of understanding of the potential benefits.
The possible cost savings of working with a more robust formulation can massively accumulate over the period of manufacture. Designing a robust formulation avoids troubleshooting activities, root cause analysis projects and costly production downtime. A well-designed formulation is also less likely to cause difficulties during change control activities related to the process or raw materials.
In addition to improved manufacturing efficiency, using compaction data during formulation improves development efficiency. Gamlen compaction data allows you to make informed formulation decisions quickly, making the process faster while also producing a better end result.
These savings easily offset the initial equipment investment. Gamlen offers many flexible options to suit a wide range of budgets. Training can be completed in less than two hours and data interpretation can be easily carried out by the novice user with the aid if the Gamlen Dashboard software.
Advantages of QbD in ongoing manufacture
Use in Ongoing Manufacture
The benefits of using compaction data extend beyond the formulation stage and into ongoing manufacture. Improved understanding of your formulation’s compaction behaviour facilitates both change control and troubleshooting in projects. Gamlen compaction data is predictive of full-scale compaction behaviour allowing you to assess the effect of any material changes before a full-scale trial. By establishing the compaction behaviour of each component of your formulation before a troubleshooting event occurs, Gamlen data also provides you with the essential data you need to make informed troubleshooting decisions with minimal material.
Talk to us about QbD in compaction analysis
The publication of USP general chapter on compression characterisation supports our belief that compaction data is an essential component of the QbD toolbox for any oral solid does product.
Contact the Gamlen team to discuss the benefits of compaction analysis for your products.