Speedy Development of ANDA Para III and IV : A Kaizen Case Study

Kaizen Case Study

Problem: A Canadian pharmaceutical company wanted to develop products for US markets (ANDA para III and IV) in their pilot manufacturing site. What changes/ upgrades may be needed? Can this be done ?

Due Diligence:  Yes, provided the pilot manufacturing plant is a part of commercial manufacturing facility and not R&D. The pilot manufacturing must have manufacturing permission of small batch sizes other than for ‘clinical trial use’. A facility audit was conducted along with USFDA regulations impact analysis.

Post assessment it was found that, the pilot manufacturing site was in compliance to US FDA norms with respect to engineering requirements for the facility.

Solution: Kaizen methodology was employed. Minor facility upgrade, major improvement in training, operating procedures, documentation and records was recommended; and successfully implemented.

Result Dashboard:

• Facility passed US FDA audit in the very first inspection.

Note: The product development strategy is very important. Product made 'glocal’ i.e. global appeal with local compliance, exhibit very little issues while expanding to newer markets. Also, it is advisable to produce at least one stability batch in pilot plant. Data from such a batch assumes great significance while discussing with FDA office.

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​Keywords and Tags:
#ContinuousImprovement   #Innovation  #Audit  #USFDA