QbD will help tremendously. (Yeah right)

LINK: http://www.pharmafile.com/news/156276/quality-design-new-manufacturing-paradigm

Is pharma ready to adopt QbD?

Most of the major pharma companies are now engaging with QbD, with numerous projects now underway. Despite this, Alpasan says many in the industry fail to understand just how big a change in culture and practices it represents.

“Companies are coming to terms with what this entails. It may be difficult or painful at the onset for the initial development projects, but ultimately the pay-off will be great, not just from a regulatory perspective but also in regard to long-term control during commercial operations for the market.”

He says an existing product approaching the end of its development, and on the verge of filling cannot be fitted into a QbD filing document for approval. Rather, it needs to be part of the plan for the product from the very beginning of its development. There is need to invest in new processes, but these costs can be recouped when QbD becomes established.

Alpasan does not believe that the QbD approach will necessarily increase the cost of manufacture unless the site has yet to implement PAT technologies. He thinks that PAT and QbD complement one another since a better understanding of the product and the process leads to a better real time control of the process. The QbD approach may increase the upfront cost of development, but there will be return on investment with better throughput for their processes and efficiency with tighter controls. Pharma should be able to avert issues with unplanned outcomes, because if they understand the product and are in control of the process and promote active trending, then uncontrolled outcomes, line shutdowns and recalls should in principle not occur.

Of course there may still be occurrences in production, but the time needed to understand and overcome problems should be less if the product and process are understood, at least with regards to the governing principles.

Adopting QbD will increase costs and development but this would be offset by more successful launches, less loss in production, fewer deviations, and fewer recalls - so there should be an overall net gain. Alpasan adds: “This expands the concept of ‘right first time’ from manufacturing and applies it to development. As with all quality initiatives, there are two approaches. One is to install culture like a piece of equipment and the other to grow it slowly from inside. I suspect the cost of QbD will be largely determined by which approach is taken.”

He says QbD should simply be seen as part of good business practice. ‘‘Companies need to realise they should be doing this because it is good business, not because the auditors are telling them to. If implemented correctly then this will decrease variation, increase quality, decrease waste, decrease costs, decrease Risk to the Patient and everybody wins.”

QbD promises to ultimately contribute to improving the safety of drugs compared to existing practices. It is widely acknowledged that the QC testing for final product release is not a statistically significant sampling, so relying on this for product quality is problematic. That is why validation of a process (with justified specifications and defined critical to quality attributes) and how that process is controlled, is key to product success.

But the implemented QbD-developed product promotes the continuous monitoring of each of the critical unit operation that is predefined, based on scientific rationale. This monitoring ensures the process is in control and also that the required product critical attributes are achieved. Thus in the long run, this approach should eliminate the need for final QC release testing and save money, eliminating QC testing and the constant investigations for OoS events that occur from lab or sampling errors.

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I don't buy QbD as being beneficial at all.

 

We have a QbD SOP, that's all we need. QbD gets in the way of quick $