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Indian pharma needs to create an environment of trust across all the levels, from the shop floor to the management cadre to offset unprecedented compliance challenges in the wake of critical findings in the audits by global regulatory agencies, experts feel.
At the concluding panel discussion on Data Integrity Challenges and Solutions for Life Sciences during the recently held India Pharma and India Medical Devices Expo 2016 held in Bengaluru, that was moderated by SM Mudda, director, global strategy (technical) Micro Labs, pharma industry experts were unanimous about the fact that companies could no longer ignore the challenges of ensuring data integrity in their enterprise.
The session focused on trends concerning data integrity and the exploration of potential solutions which was seen to benefit all departments of the company from manufacturing, analytical development, laboratory, research and development, quality assurance, quality control to regulatory affairs.
According to Rajiv Joshi, partner, fraud investigation and dispute services, Ernst & Young, there was an urgent need to move from manual to automation in all processes. It is not just about organising training sessions or installing a software on compliance but demonstrating transparency in reporting by putting in dash boards across workforce stations. In this regard, it is vital to create a positive and enabling environment to put in place quality management systems.
FDA is focusing on quality metrics initiative that serves as a measure of compliance ability of an organisation with the GMPs. However, in order to ensure a sustainable compliance, the companies must include meaningful optional leading indicators in the Quality Metrics for measuring company's quality culture that was found to have a significant relationship with the company's quality performance, said Mudda.
“Quality assurance should begin from the top”, said SV Veerramani, president, Indian Drug Manufacturers Association and CMD, Fourrts. Emphasizing on the need of following the authorised instructions, he stated that the straight line is the shortest line between two points and advised to comply with instructions without short cuts.
Dr. Parizad Elchidana, managing director, Apotex Research said that data integrity is not restricted to laboratory data alone, as is commonly believed, but applies to the data generated in all GMP activities and data from R&D and clinical studies throughout the product life cycle. The best way to identify the potential data integrity issues is to create an atmosphere where employees will approach the management freely for transparent reporting of such issues.
It is vital to continue lean meetings at the labs and shop floor for reviewing and sharing of issues related to data integrity which has ensured efficiencies as the initiatives have helped companies like ours, said Dr. Elchidana.
Jerry Brown, Sr. VP Industry Solutions, Emerson Process Management, USA stated that while software-based automated systems will help resolve data integrity issues, it is important that they are implemented through the quality systems based on soundly designed protocols.
K V Varkey, MD, Hindustan Antibiotics Ltd, Pune; Dr. T Ravichandran, director, NIPER, Kolkata; and K.M. Prasad, M.D. KAPL, Bengaluru who participated actively in the panel discussion pointed out that a systematic adoption of quality management system could enable companies to face unprecedented compliance issues in ensuring data integrity.
The Indian companies need to put in place data governance system as a part of quality management system providing a data integrity policy, systems and procedure among others, concluded the experts.
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