SP: We continue to see warning letters to manufacturers and clinical labs in Asia on data integrity and the trend has been increasing for the past 2-3 years. Data Integrity is a global problem but it is probably a bigger concern in Asia than other parts due to the number of suppliers. I think it is very important for the industry to take a concerted effort to build or re-build the confidence in Asia to be able to compete for investment, fuel Asia's growth and improve supply reliability.  With the tightening of inspection approaches, the industry has to begin programs to ensure that their processes and systems ensure data integrity.

ISPE SG: What has been the greatest challenge that you faced and how was it overcome?

SP: One of the current challenges for a Quality profession is how to build digital capability knowledge to bring value to our customers. There are unclear digital standards, data security concerns and often, unclear economic benefit. For example, I believe that e-labeling has the potential to exert a significant impact on product design, manufacture, and distribution but the adoption interest is not strong in Asia. I hope to see increased support and certainly the Asian policymakers can accelerate building the capability. Talent development is key and we are focusing on bringing the best brains together.

 

ISPE SG: How can ISPE best help professionals in this region?

SP: ISPE Singapore is already engaging the professionals through the various channels of education. Perhaps to strategise the programs for local and global relevance will benefit the professionals more. There is a shift for Pharma companies to seek more and more partnerships driven by cost savings, speed to market, technical expertise and increased efficiency. There is however a growing concern in the GMP lapses in the contract manufacturers in Asia. I believe that ISPE can play a pivotal role to support the local manufacturers and close the enforcement gaps by inspections between the different GMP standards. Through the collaboration with regulators and stakeholders, ISPE can support in the design of training curricula to improve data integrity management and implement quality by design for the local market.

 

ISPE SG: What advice would you like to share with young professionals embarking on a career in this industry?

SP : I'd like to advise young professionals especially female professionals that career advancement is direct and remarkably gender free: be yourself. We all value sincerity and it is being yourself that your value will be differentiated. Communications is a significant skill for all pharma professionals and a career builder. There is a lot of focus on technical proficiency but the ability to forge useful connections with diverse stakeholders is what makes business a conversation and personal.