Indian pharma industry is currently facing the challenge of dealing with data integrity issues during the international regulatory inspections despite the remarkable progress of the sector in the global arena as a leading manufacturer of active pharmaceutical ingredients (APIs) and formulations. The need of the hour is to move away from the traditional approach of product quality and good manufacturing practices (GMP) compliance which does not seem to encourage adoption of modern system-based approach and focus on behavioural aspects rather than technical issues, said SM Mudda, executive director – technical & operations Micro Labs Limited.
It is time that the Indian pharma counsel its personnel. It should not restrict its focus only on need–based, risk averse and inspection-oriented compliance. Instead, the industry would need to embark on an employee engagement exercise and take immediate steps to create a quality mindset right from the management to shop floor, he added.
“In terms of Maslow's theory of motivation, the motivating factors in key professionals, despite demonstrating their ability to manufacture best-quality products, unfortunately appears to have come down to the level of merely fulfilling basic needs. It involves need for protection rather than growth needs, where each individual is self- motivated to achieve personal excellence. The fear of failure appears to be one of the contributing factors for professionals in view of the overall criticism of the practices followed, said Mudda in his presentation on ‘ Motivating quality and operation teams to quality systems compliance’ at the Indian Pharmaceutical Association Platinum jubilee event recently.
While steps are initiated in creating a culture of quality and compliance in the industry, the immediate concern seems to be to create a hygienic environment where every individual is encouraged to comply with the regulatory requirements keeping patient safety in mind.
Quoting Deming's 94/6 Rule, he said that 94 per cent problems are caused by the system and 6 per cent by the individual. At least 85 per cent efficiency of the operating staff comes from the work environment and balance from his skills, said Mudda adding that adoption of Pharmaceutical Quality System or ICH Q 10 is the way forward to create a conducive environment which encourages quality culture across the organisation. Therefore, developing second level leadership which is motivated to implement the top management commitment to quality, in letter and spirit, is necessary, he noted.
In order to bring back the reputation of high quality standards, Indian pharma industry needs to ensure reducing the fear of errors. The industry will need to foster a culture of error management. This would help in fearless and transparent communication of errors where mistakes are analysed and lessons are learnt from the slip-ups. There is need to help the workforce to do a better job, break down barriers between departments, eliminate management by objectives and substitute it with leadership, said Mudda.