Valsartan, Irbesartan, Losartan product recalls- What are the lessons for Pharmaceutical Industry?
Straight answer- Big Time Business Process issue which must be rectified ASAP...
And, these 'process issues' are at several areas viz. product development process, manufacturing process, outsourcing or procurement process, customer service process to name a few; though a company-specific root cause investigation will indicate more business processes that might have fully or partially impacted this drug product recall mess.
Presence of a potential carcinogen impurity in the drug as well as drug product clearly shows flaws in 'development and manufacturing processes'.
Companies that purchased this potentially contaminated API (active pharmaceutical ingredient) obviously have huge flaws with their 'procurement / outsourcing process' and need immediate process re-design!
The fact that, carcinogen-contaminated drug products were consumed by patients show huge issues with 'customer service processes' of pharma companies and pharmacies. The issue with 'customer service process' gets further augmented because of the drug product shortage scenarios patients must now deal with.
As these recalls are not just with native irbesartan, valsartan, losartan products, but also extended to their fixed dose combinations i.e. *sartan combined with other drugs such as amlodipine, hydrochlorothiazide etc., the product shortage mess gets sticky. Further, since these products are consumed daily, the impact of product shortages on patients (i.e. customers) is more intense...
- A logical thing to do in such cases is to study the Value Stream Map and identify all business processes that might have contributed to this mess.
- Next take a call on where these 'problematic' processes must be improved or re-designed. You can learn more about business process improvement and redesign here.
- Improve or redesign process(es) by using appropriate business improvement methodologies. There are over 18 different business improvement methodologies to choose from. Note that, selection of correct business process improvement methodology is very important too.
- Once the problematic process(es) have been improved or redesigned as the case may be, conduct a robust risk-management exercise with FMEA and install a CAPA.
- Supplementing CAPA with Error-proofing mechanisms via Poka Yoke highly guarantees a 'no risk' scenario.
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