Regulatory Affairs has always been considered as a Drug registration department in Indian Pharmaceutical industry. When Drug
Registration and Marketing approvals are essential day to day activities of a regulatory professional, there is lot more aspects
bound to it beyond product registration. In a true scenario, Regulatory Affairs is a horizontal that cut across the Pharmaceutical
Value chain right from Drug discovery, Drug Development, Manufacturing, Sales and Marketing and Post Marketing. In all of
these phases there are number of compliance parameters to be met in order to pass the stringent regulatory scrutiny. Regulatory
Compliance plays an integral role in Regulatory Affairs. It is a common belief that, when the product complies with its specification
then quality is achieved. Testing the final product cannot assure the quality unless and otherwise it is built into the product itself.
The concept of Quality by Design (QbD) helps in building the right product with a thorough understanding of the product and
process by which it is developed. QbD applies equally to the software used in the Pharmaceutical Industry. Understanding and
interpreting these regulations has always been a challenge in Pharma because Regulations like US FDA or UKMHRA would only
provide the guidance document on its interested topics, the how aspect is left to the Pharmaceutical Company. Complying with
these regulations is purely based on a company?s internal policies and Procedures. Despite these regulations exist for so many
years now, even today there are so many non- conformances and FDA 483s. What is the challenge? Why compliance is always
considered as a painful exercise? What role does a Regulatory Affairs professional play in this entire process?
Wait and watch my session for the answers.
Amudha Krishnamoorthy is a Life Sciences Quality and Regulatory Consultant having 15 years of Experience. She has served in Departments like
Manufacturing, Quality Assurance and Regulatory Affairs in her Pharmaceutical Industry career and currently working as a Regulatory Consultant
in IT Company. Her expertise includes GxP Compliance, Software Compliance and Regulatory Submissions. She is also a certified mentor for Life
Sciences imparting domain knowledge to the IT folks.
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