Quality: From Compliance To Culture

As custodians to ensure patient safety, quality teams in pharma firms must have a mechanism not only to comply but to consistently comply, says Rashida Najmi, Senior Vice President, Global Quality, Regulatory, Pharmacovigilance and Patents, Piramal Enterprises. For this to happen, compliance to quality needs to become part of the culture of a company

Dear friends in the pharmaceutical space. Having spent more than 30 years in pharma quality, through this publication I aim to create a general awareness on quality culture. I fully recognise that the content in this article is based on my views and there can be an alternate or contradictory view which may be equally valid.

Often times in various events and conferences that I attend outside pharma quality, it makes me ponder about the fast pace at which several other high risk industries (like automobile, aerospace, banking etc) have grown leaving pharma to be viewed as a snail in bringing innovation to market. The time to market for any pharma discovery is on an average 12.5 years with the cost of over £1 billion. There is also high degree of molecule attrition as the journey progresses on the drug development life cycle.

Why does pharma take a conservative approach?

There is a reason behind such a conventional approach to drug development and licensing process. The most significant reason is delayed knowledge of its adverse outcome and low possibility of its retraction once consumed. Unlike faulty cars, air planes, etc. which can be possibly recalled, drugs once administered cannot be retrieved back from the patient’s body. Similarly, while risk to human life due to faulty cars and jet planes can be as huge, the risk is known immediately if it crashes. In the case of medicines, the risks could be evident after several years, decades or generations. These are the factors that make pharma researchers and regulators take a conservative approach.