As India Parma Inc strives to transform into a more value-led and innovation-driven industry, it has to develop strategic capabilities to leverage scientific expertise and meet the needs of evolving regulatory environments across the globe.
Therefore, Dhaval Kumar Surti, Head-Quality Assurance, Dr Reddy’s Laboratories, spoke on how to attain business sustainability through compliance, process excellence and process simplification. He drew insights and inferences from over 19 years of experience in injectable manufacturing, validation, quality assurance and new facility projects.
Surti highlighted that process understanding is the first step to achieve process excellence.
Opining that nowadays, most failures and observations are not just due to old
machines, old facilities and lack of automation, but due to ‘lack of basic understanding of people,’ he said that technology is updated but simultaneous pace in increased expertise of operating personnel is not observed. The first is to understand why the process is complex and figure out the scope for human errors. Then, listen to the people involved in the activity and train to connect their inputs to expertise. Other measures to bridge the gaps include improving design control/automation/procedural control.
He urged the industry to plan well, identify and break down silos as well as dissolve inter-departmental boundaries. He also said that each employee should become a hero of his/her domain to ensure process excellence and compliance.