Indian pharma industry needs to respond to the challenges of quality issues and regulatory challenges by adopting a paradigm shift in its approach towards good manufacturing practices (GMP) compliance. It is observed that the contributing factors towards poor GMP compliance are more behavioural than technical. Therefore, drug manufacturers need to make a radical move to focus on Key Behavioural Indicators (KBI) over Key Performance Indicators (KPI), said SM Mudda, director, global strategy (technical), Micro Labs.

The behavioural aspects that could individually or in combination could lead to failure are institutional arrogance, poor attitude to problems, panic, stress, fatigue, bad institutional habits, hierarchy, lack of personal integrity and honesty, culture of fear and blame. Similarly on the technical side, there is lack of investigational skills, ignorance due to poor education, system that encourages bad practices and poor performance management making our compliance with GMPs to be consistently inconsistent, he added.

In his deliberations on 'Pharmaceutical Industry-Quality Issues & Regulatory Challenges', Mudda cautioned that the industry must take a serious note of the change in the inspection process that focuses on identifying behaviours that could be termed as falsification in the context of GMP compliance. Any willful misstatement, misrepresentation, manipulation, adulteration, rewriting, hiding of quality related documents, in order to give an item the appearance of GMP compliance when this is not the case, is seen as an attempt to falsify.

“The underlying reason for failure is that our compliance to GMP is more need-based and is not supported by a management structure or platform, said Mudda at the Pharmexcil Bengaluru branch inauguration seminar that focused on 'Export Opportunities and Regulatory Challenges'. It is high time to look beyond the practices and understand concepts behind the practices,” he said.

In fact, the industry will need to counter this with a systematic approach and adopt quality management system (QMS) as a structure for a sustainable and consistent implementation of GMPs. It is vital to comprehend that practices without the support of the philosophy can never be implemented consistently since the concepts teach us the purpose of each practice and QMS precisely does this. In this regard, the industry will need to redefine the ‘C’ in the cGMP as ‘Creating, Culture of Compliance', he stated.

Adoption of Pharmaceutical Quality Systems (PQS) will help create a second level leadership committed to quality policy of the management in letter and spirit. It will encourage continual improvement and ensure top management commitment to quality and protect the company’s reputation. Therefore, moving from mere compliance with 'good' practices to adoption of QMS will help overcome challenges of ever increasing regulatory requirements, stated the Micro Labs director of global strategy.