Whether life-saving or taken just to cure a headache, drugs have a critical role to play. And that is why the pharmaceutical business is governed by several regulations and quality specifications.
Three recent news items though makes one wonder where and how the breach occurred. An Indian plant of a leading global pharma company, where injectables and solid dosages are manufactured, was issued a notice for not meeting quality standards.
In another plant of the same company manufacturing heart pills, there was evidence of urine spilling over open drains, soiled uniforms and mold growing in a raw-material storage area.
Another Indian manufacturing arm of an international pharma company has also been asked to stop imports due to multiple violations at the factory.
According to Dr. Shridhar Lolla, a business coach, the nature of most of the issues being highlighted is related more to management systems than technical quality. There is a high degree of distrust and also negligence in following simple norms.
“Assuming that people are good, if people are forced to over work in a situation that reduces their span of attention,mistakes like supply of wrong medicines, broken tablets, untested medicines etc. do occur.
But outside pharma industry such problems have been solved to an extent by Six Sigma (i.e. less than 4 defects per million opportunities).”
At least one thing pharma companies can do is to reduce the pressure on their staff in mindlessly chasing higher throughput as if there is not another day left to make money. This can be ensured only if the plants do not create traffic jam type of situation in their shop floors by following the good practices of operational management.
He tackles just such issues in his book ‘The Path’ (Published by Productivity & Quality Publishing Pvt Ltd) and suggests a way out. This book is for all those who put quality and customers before everything else.