Indian pharma industry needs to aim at creating continuity in learning to sustain a culture of quality, said SM Mudda, executive director, Technical & Operations, Micro Labs and member, Committee of Administration, Pharmexcil.
A challenge in the pharma industry today, not just in India but globally, is the concern on quality and enabling and implementing new learnings in quality management systems, he added.
The way forward for Indian pharma would be to adopt the Quality Management System (QMS) which is a platform to implement good manufacturing practices (GMPs). Usually, an inspection could have fallen short when a company’s management processes and risk identification may have failed. Automation and computerisation aid in GMP compliance. The successful adoption of technology by the pharma industry would improve quality and reduce errors,” Mudda told Pharmabiz in an interaction.
“Adherence to GMP should ensure consistency, however, it is due to the lack of uniformity in implementation, the good practices are seen to be consistently inconsistent. The industry needs to respond to this challenge with a paradigm shift in its approach towards QMS to ensure compliance,” said Mudda.
India has the expertise in terms of world-class facilities, technical knowhow and qualified human resources. All it needs is to implement and sustain a culture of quality.
In order to achieve this, the Pharmexcil has a plan to create a long-term education platform to enable industry professionals adhere to Best- Practice Pharmaceutical Quality System.
“This is a first of its kind education training for the pharma industry organised by Pharmexcil. It would be a precursor for a long-term permanent education platform because QMS is the foundation of GMP. Therefore it is vital to create a platform of good quality thinkers and groom future pharma professionals, pointed out Mudda.
Pharmexcil is in discussion with eminent quality management thought leaders from Europe and US. It is working to finalise a curriculum and the programme will include current topics covering behavioural and technical aspects. It will be aimed at creating second level quality leadership in the industry. It will provide a road map on the quality culture and compliance. The participants will be selected from the member companies of Pharmexcil and IDMA.
In fact on the occasion of its 10th Pharmaexcil annual general meet to be held in Hyderabad on September 18 and 19, 2014, a technical seminar on ‘Best- Practice Pharmaceutical Quality System- The Way Forward for Quality Culture & Compliance’ has been planned. Several global experts on quality systems, documentation and data integrity like Dr Ajaz Hussain, Ex-US FDA, Bruce Davis UK Consultant, Suraj Baloda, USA Dr Eduardo Heidelberg, USA will speak.