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APIs See Continuous Improvement…but Only Until Clinical Trials

In what can best be described as a quality paradox, continuous process improvement has become something of a buzzword in the pharma manufacturing industry. But, as Epcot President & CPhI expert Girish Malhotra points out in call for regulatory reform at Pharmaceutical Technology, it’s also misleading notion.

Why? Because once drugs (or their processes) head into clinical trials, they are locked into the ‘DO NOT TOUCH’ museum – never to be modified, improved or otherwise altered.

Regulatory reforms often play catch-up with the reality on the ground, so to speak. I alluded to this issue in an earlier post on establishing real-world thresholds for genotoxic impurities. Regulatory regimes take time to adapt to advances in pharma and biopharma – and often only do so when pushed by industry.

Over the years, I’ve written on a number of issues that are prime candidates for process improvement. In most cases, these improvements tend to find their way into the next project or product, so that they may be incorporated without significant regulatory issues – namely higher costs and lengthier time to market (via re-approval).

Continuous improvement’ – in such cases – has mostly come to mean continuous improvement of methodologies, processes, and procedures with implementation occurring only with the next compound or API, and not the one in question – the core of the current regulatory framework failure recognized by Girish Malhotra in the PharmTech article.

Malhotra recommends placing the burden instead on the company:

“(T)he industry should be allowed to commercialize process improvements (whether it’s yield, process/operating conditions, operating parameters, or cycle time) in the manufacture of approved APIs and their formulations without regulatory re-approval. It is the responsibility of the manufacturer to provide guarantee that the changes will not affect product efficacy and performance.”

It’s worth a read (and the PharmTech article includes a link to the full text in the CPhI annual report, as well). If the objective is to manufacture the best APIs possible, his recommendation is a good start for a discussion we certainly should be having.

What are your thoughts on continuous improvement?

 

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